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Medtronic Pacemaker Battery Drain Defect Linked to 1 Death

Medtronic Pacemaker Battery Drain Defect Linked to 1 Death

May 9, 2019 — Medtronic and the FDA are alerting patients and doctors about reports of rapid battery depletion on pacemakers and CRT-P devices, including 1 person who died as a result.

The FDA warning says it is aware of 3 reports in which a Medtronic pacemaker or CRT-P device’s battery had fully drained because of a crack in the device’s capacitor, without any warning.

The batteries may drain completely within a few days. In all 3 cases, the failures occurred within 9 months of the device being implanted.

The problem affects approximately 131,889 devices that were sold in the U.S., including the following pacemaker and CRT-P implants:

  • 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

The defective part is capacitor, which is supposed to store electrical energy. The problem is that a crack may develop in the capacitor and create an electrical short-circuit that drains the battery within days.

At least one pacemaker-dependent patient died as a result of the problem. A second patient had to have their pacemaker replaced after experiencing dizziness, and their healthcare provider was unable to communicate with the device because the battery was drained.

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