Medtronic Sprint Fidelis Defibrillator Leads

RSS
Modified on 2009/10/14 21:34 by admin
 

Medtronic Inc., one of the world’s leading medical technology companies, was founded in 1949. The company began in a garage in Minneapolis and sold medical equipment manufactured by other companies.

Medtronic began producing its own medical equipment in the 1950s. Medtronic is credited with manufacturing the first wearable artificial pacemaker in 1957. In 1960, they created the first reliable long-term implantable pacing system.

Medtronic News and Recalls

December 2007

Medtronic, Inc. agreed upon a settlement relating to its Marquis line of implanted cardiac defibrillators that were involved in a field action from February 2005.

Medtronic announced an agreement to settle 2,682 cases for $95.6 million along with an additional $18.5 million in attorney’s fees. Both parties agreed to file a joint request for termination of the Multi-District Litigation (MDL) proceedings that involve Marquis Devices, along with a request to dismiss all involved cases. The settlement may be severed by either party if the MDL proceedings are not severed.

All plaintiffs who agreed to the settlement terms must satisfy any outstanding insurance claims and subrogation interests of Medicare and Medicaid from their settlement payments. Medtronic will not pay additional funds for these cases, attorney’s fees or third-party claims.

The settlements came as compromise to settle disputed claims. Neither party admitted to any liability or validity of any defenses in the litigation.

December 2007

A Medtronic investor filed a lawsuit against Medtronic, Inc. in the U.S. District Court of Minneapolis, where the company headquarters are located. The suit sought class action certification on behalf of all Medtronic investors who invested in the company’s stock between June 25th and October 15, 2007 – the day Medtronic announced a recall of its Sprint Fidelis defibrillator leads.

The Complaint charged Medtronic and certain directors with violations of the Securities Exchange Act of 1934. The Plaintiff sought to recover damages on behalf of all class members involved.

The suit alleged Medtronic made many false and misleading statements about their Sprint Fidelis defibrillator leads while knowing the leads were defective and malfunctioning.

October 2007

The FDA issued a Class 1 Recall for Medtronic Incorporated's device named Sprint Fidelis® Defibrillator Leads The model numbers of the recalled defibrillator leads; 6930, 6931, 6948 and 6949. The recalled leads were used in defibrillators manufactured from September 2004 through October 15, 2007. Class 1 Recalls are used by the FDA when there is reasonable evidence to believe that a product or drug may cause serious injury or death.

Medtronic's Sprint Fidelis defibrillator leads were recalled due to a small number of fractures found in the devices which could cause inappropriate shocks or result in a loss of therapy. This would lead to a failure of the device to perform its normal functions, with health risks to the patient. The Sprint Fidelis "Leads" are very thin wires connecting the implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart. These devices (ICDs and CRT-Ds) were used to treat abnormal heart rhythms which can result in sudden and dangerous heart stoppage which may cause death or serious injury. 

Some patients who have filed suit against Medtronic allege they received up to 47 unnecessary shocks due to a fracture in the Sprint Fidelis lead wire. If you or a family member has suffered an injury as a result of this (or any other defective medical device) you may request a free consultation with an attorney.

Just prior to this Class 1 recall, Medtronic issued their own "voluntary suspension of sales and marketing" of the Sprint Fidelis Defibrillator Leads.

Several patients who were injured after being implanted with a Sprint Fidelis lead wire alleged in Medtronic lawsuits that the company was aware of the potential risks and dangers posed by its device long before they issued an official recall of Sprint Fidelis defibrillator lead wires, in October 2007.

Medtronic ultimately recalled the Sprint Fidelis defibrillator leads after they were linked to the deaths of at least five patients who had been implanted with the device.

Experts expected many of the 250,000 patients implanted with Sprint Fidelis defibrillator leads to file lawsuits against the company. One expert believed that even more Medtronic lawsuits could be expected from the Sprint Fidelis recall in comparison to the 2005 Marquis Defibrillator recall.

The Food and Drug Administration (FDA) estimates that almost 600 patients suffered injury while wearing a defibrillator that contained one of the recalled Sprint Fidelis leads.

Medtronic has said that about one in every 43 patients implanted with a defibrillator containing a Sprint Fidelis defibrillator lead will experience a fracture within 30 months from the date of implantation.

While Physicians do not recommend patients having their defibrillators replaced, they do advise patients to speak with their doctors and to have their defibrillators inspected to determine if the device is working properly to eliminate any risk of danger or serious injury.

Medtronic has instructed doctors and hospitals to stop using the product and to return any leads with these models to the manufacturers. Patients with the devices may call Medtronic Patient Services at 1-800-551-5544 X41835 (7 am to 9 pm Central Standard Time). If you have a Medtronic device and are unsure of the model number or whether it has potential to be defective, consult your physician and obtain your medical records.

Additional information from the FDA regarding Medtronic Recalls.

September 2006

The FDA warned Medtronic regarding the delayed filing of a report regarding the AneuRx Stent Graft System. The purpose of the study is to make sure the device is properly labeled for use and to ensure training for health care providers using the device.  The AneuRx Stent Graft System is used to treat abdominal aortic aneurysms and was approved in 1999. The interim post-market surveillance report was filed on an annual basis until then. The FDA issued alerts and recalls involving more than a few hundred thousand defibrillators in the past twenty years.

February 2005

Medtronic began advising physicians about a potential shorting in the battery mechanism that may occur in various Marquis-brand defibrillators.

In the letter sent to physicians, Medtronic reported that nine batteries (about 1 in 10,000) experienced rapid battery depletion caused by the shorting action. If shorting occurred, battery depletion could take place within a few hours to a few days, after which the device failed to function at all. There were no reported deaths or injuries as of this date.

Devices using batteries manufactured between the April 2001 and December 2003 were at risk for shorting. Potentially affected models included the Marquis VR/DR and Maximo VR/DR ICDs and the InSync I/II/III Marquis and InSync III Protect CRT-D devices.

Of these devices, approximately 75 percent were implanted in the United States.

August 2004

The FDA issued a Class I Recall for the software application Medtronic 8870 Software Application Card Version AAA 02. The FDA reported that the software, used with Model 8840 N’Vision Clinician Programmer, which controls the amount of medication administered in Synchromed and Synchromed EL implantable infusion pumps, was recalled because of reports of "hours" into the "minutes" field of the application, which resulted in reported serious injuries and deaths.

April 2004

Minnesota defibrillator manufacturer Medtronic recalled two models after receiving several reports that the devices did not charge properly and failed to shock a patient's heart when required. Medtronic removed Micro Jewel II Model 7223Cx and GEM DR Model 7271 ICDs due to malfunctions that were linked to four deaths and one injury. The company said the defibrillators were taking a dangerously long time to charge.

According to Medtronic, over 6,000 of the recalled models were manufactured and implanted in 1997 and 1998. Nearly 2,000 were suspected to still be in use as of the recall. The company alerted physicians to test the charge capability of Micro Jewel and GEM model defibrillators implanted in patients.

2002

Medtronic requested the sealing of records involving a defective product lawsuit filed on behalf of a woman who was put in a coma as a result of an injury alleged to have been created by the defective device.

If you have experienced serious health problems due to a cardiovascular device, it may be important to contact an attorney who can help you protect your legal rights. Please keep in mind that there may be time limits within which you must commence suit.

Defibrillator Recall Lawyers associated with InjuryBoard can help track down medical records that show if a patient is implanted with a Sprint Fidelis defibrillator lead included in the recall. Patients who do have one of the recalled leads may be eligible for compensation in the event that they have been injured due to the device malfunctioning or working incorrectly.

Attorneys associated with InjuryBoard.com will evaluate your case free of charge. In addition, you will not pay any fees unless your attorney recovers money for you. Patients may be eligible for compensation of medical care and/or surgery relating to defective defibrillators. Please click on the free Ask An Attorney button to take advantage of this valuable service.

 



See Also

  1. Medical Devices & Implants
  2. Overdose: Overview
  Name Size