May 9, 2019 — After 1 patient died because the battery ran out suddenly on their pacemaker, Medtronic is warning about a defective part that can cause rapid battery depletion.
Medtronic pacemakers and Cardiac Resynchronization Therapy Pacemaker (CRT-P) devices are implanted in patients with heart failure or heart rhythm problems.
The FDA is warning patients and doctors about 3 reports of the batteries draining completely — sometimes within days — and with no warning.
The problem is linked to a defective capacitor, which is a part that is supposed to store electrical energy. A crack in the capacitor can cause an electrical short-circuit, resulting in rapid battery draining.
One patient died as a result of their pacemaker running out of batteries. A second patient experiencing dizziness, and the device was removed and replaced because their healthcare provider was unable to communicate with it because the battery was fully drained.
The problem affects approximately 131,889 devices in the U.S.:
- Azure models: W1DR01, W2DR01, W3DR01, W1SR01, W2SR01, W3SR01
- Astra models: X1DR01, X2DR01, X3DR01, X1SR01, X2SR01, X3SR01
- Percepta models: W1TR01, W1TR04, W4TR01, W4TR04
- Serena models: W1TR02, W1TR05, W4TR02, W4TR05
- Solara models: W1TR03, W1TR06, W4TR03, W4TR06
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