Medtronic Pacemaker Battery Lawsuits

FDA Issues an ALERT About a Potentially Fatal Defect

 Medtronic Pacemaker Batteries Drain Suddenly 

On May 7, 2019, the FDA issued an alert warning about a potentially fatal defect in certain Medtronic pacemaker devices that causes the battery to rapidly drain without warning.

The alert went out to patients, caregivers, cardiologists,and medical professionals using a Medtronic implantable pacemaker or resynchronization therapy pacemakers ( CRT-Ps) to treat patients with heart failure or heart rhythm problems. These pacemakers regulate the heartbeat and keep the heart beating.

Manufacturing Defect in the Medtronic Pacemaker Capacitor

The Medtronic devices are powered by lithium-ion batteries. One key part is a capacitor, which stores electrical energy. The FDA warned of reports where a Medtronic implantable pacemaker or CRT-P battery had fully drained because of a crack in the device’s capacitor with no warning to the patient or health care provider.

Medtronic internal documents say the cracking can be caused by “thermal-mechanical stress during manufacturing.” Medtronic says the problem is not related to battery performance. Instead, the cracked capacitor can create an electrical short which drains the battery quickly. 

These devices are designed to last between 6 to 15 years before needing a battery replacement. Medtronic pacemakers with capacitor cracks have been failing within the first 2 to 10 months. 

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Medtronic Pacemaker Models in the FDA alert

Medtronic has sold 266,700 susceptible pacemaker devices since Feb 2017.  Affected Medtronic implantable pacemaker and CRT-P models include:

  • Azure models: W1DR01, W2DR01, W3DR01,W1SR01, W2SR01, W3SR01
  • Astra models: X1DR01, X2DR01, X3DR01, X1SRO1, X2SR01, X3SR01
  • Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
  • Serena models: W1TR02, W1TR05, W4TR02, W4TR05
  • Solara models: W1TR03, W1TR06, W4TR03, W4TR06
medtronics pacemaker lawsuit
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Our attorneys represent people across the entire United States. We are not local personal injury attorneys. We are a medical product liability law firm with decades of experience in Federal and State courts all over the country. We have the reputation of aggressively and successfully representing our clients against huge corporations during negotiations and in jury trials.

We Represent People with Medically Complex Issues Every Day

Medical product liability lawsuits are NOT simple personal injury cases. Your attorney must have an understanding of complex medical issues involving these defective devices and drugs.  The medical product liability team at mctlaw helps clients every day with rare and complicated medical diagnoses. We thoroughly review clients’ medical records to find evidence to support their claims.