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Medtronic Pacemakers

Medtronic Pacemakers Side Effects Lawsuits | Side Effects: Injury | Wire Breakage

Medtronic Pacemakers Side Effects May Lead To Personal Injury Lawsuits

Medtronic Pacemakers | Lawsuits, Lawyers | Side Effects: Personal Injury | Wire Breakage

Medtronic Inc. announced they are advising physicians of a potential problem in a small number of its Sigma pacemakers in which wires may separate from a circuit. No deaths or injuries were reported, though some users suffered dizziness or fainting, according to the Fridley-based medical-devices maker. An estimated 28,000 pacemakers, including 6,650 in the U.S., are covered by the advisory, which Medtronic said could be classified by the U.S. Food and Drug Administration as a recall.

Medtronic said the defect took place when a solvent used to clean pacemaker wires degraded them over time, causing the wires to break from the circuitry in 19 devices. Pacemakers help spark the heart to achieve a steady, timely beat. The company estimates that 47 to 84 units, all made between November 2001 and August 2004, could be affected over the 10-year life of the units.

The risk to patients is extremely low, but we are alerting physicians to the issue to ensure they are aware of the situation and can appropriately care for their patients," said Steve Mahle, president of Medtronic's cardiac rhythm management division.

Although the company doesn't recommend replacing the devices prior to normal elective replacement, it added that this decision should be left up to the doctor based on each patients unique circumstances.

Legal Help For Victims Affected By Medtronic Pacemakers

If you or a loved one suffered injuries from a Medtronic Pacemaker, please fill out the form at the right for a free case evaluation by a qualified defective medical device attorney or call us at 1-800-YOURLAWYER (1-800-968-7529).


Medtronic PacemakersRSS Feed

Medtronic Recalls 100,000 InSync III Pacemakers Due to Battery Defect

Dec 8, 2015
Medtronic Recalled InSync III Pacemaker Due To Potential Battery Defect Medtronic recalled nearly 100,000 InSync III pacemakers due to a potential battery defect that could cause malfunction. Qmed reports that the U.S. Food and Drug Administration (FDA) has designated the recall as Class 2, meaning that exposure to the recalled product may lead to reversible adverse health effects or that there is a remote chance of serious health consequences. In an Urgent Medical Device Correction,...

Medtronic Resolves Whistleblower Case for $9.9 Million

Jun 2, 2014
Medtronic is resolving a whistleblower case for $9.9 million, the Department of Justice announced Wednesday. According to the DOJ news release, the company allegedly paid illegal kickbacks to physicians in order to promote implantation of their pacemakers and defibrillators (). Assistant Attorney General Stuart F. Delery of the Justice Department’s Civil Division said in the release “Improper financial incentives have the potential to compromise physician medical judgment…...

Medtronic Announces Layoffs, as Infuse Controversies Drag Down Sales

Sep 28, 2012 | Parker Waichman LLP
Medtronic announced in May it would be cutting some 1,000 jobs, as the controversy surrounding its Infuse Bone Graft product continues to weigh on the medical device maker’s bottom line.  "We are eliminating about 1,000 positions around the company and around the globe," Gary Ellis, the company's chief financial officer, told the Minneapolis Star Tribune at the time. "It's kind of the normal, ongoing thing that goes forward as we shift resources from slower-growing markets to ...

Changing ICD generator elevates risk factor for Sprint Fidelis lead failures

Jun 18, 2012 | Parker Waichman LLP
Patients relying on an implantable cardiac defibrillator (ICD) are more likely to experience malfunctions and failures with the Sprint Fidelis leads connecting it to the heart if they change the device's generator. According to a report at, new research from Emory University identified changing the generator on an ICD device while keeping the Sprint Fidelis leads would likely lead to a device failure. The Sprint Fidelis lead was recalled in 2007 following scores of reports of its...

Medtronic Unit Settles Defective Spine Device Lawsuit

Apr 29, 2011 | Parker Waichman LLP
A lawsuit involving the Danek 3-D TSRH Spinal System made by a unit of Medtronic Inc.  has been settled, according to a report from Law360.   The lawsuit was brought by a Puerto Rican woman and her family who claimed the Danek 3-D TSRH Spinal System caused her to suffer serious and life threatening injuries.According to Law360, the Danek 3-D TSRH Spinal was recalled by the U.S. Food & Drug Administration (FDA) because of a manufacturing defect that could cause the implant to...

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