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Medtronic Pacemakers

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

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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 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 TheHeart.org, 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...

Medtronic Says California Seeking Info on Heart Rhythm Devices

Dec 10, 2009 | Parker Waichman LLP
Medtronic Inc. is being investigated in California over its heart rhythm devices.  According to The Wall Street Journal, Medtronic recently disclosed that it had received a subpoena from the Department of Health and Human Services' Office of Inspector General in California.Medtronic reported the subpoena in a quarterly filing with the Securities and Exchange Commission (SEC) it had made on Wednesday.  The disclosure read as follows:"On September 16, 2009, the Company received a...

Medtronic Cardiac Rhythm Disease Management Site Gets FDA Warning Letter

Nov 19, 2009 | Parker Waichman LLP
Device maker giant, Medtronic, Inc., just announced that it received a warning letter from the U.S. Food & Drug Administration (FDA).According to the Twin Cities Business Journal, the letter came after an inspection of Medtronic’s Mounds View Cardiac Rhythm Disease Management site and concerned: “Corrective and preventative action and field-action timeliness, review and documentation of field action recommendations, supplier qualification and controls, and medical-device...

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