Potential Rapid Battery Depletion
EnTrust® VR/DR/AT ICDs
Original Date of Advisory:
All EnTrust ICDs
A small percentage of EnTrust ICDs may not meet expected longevity or provide at least three months of device operation between the Elective Replacement Indicator (ERI) and End of Life (EOL) due to a more-rapid-than-expected drop in battery voltage. An estimated 39,000 EnTrust ICDs are currently implanted worldwide. No patient deaths or serious injuries have been reported as a result of this issue.
The reported events have involved a drop in battery voltage from ~3.0 V to ERI (2.61 V) over a time period ranging from approximately one week to six months. All reported events have occurred at least 30 months after implant.
Medtronic has identified the cause of these occurrences to be an internal battery short that develops as the battery capacity is consumed.The exact sequence of events and use conditions that lead to the battery short is still being investigated.
Patient Management Recommendations (As of March 2012)
After consultation with Medtronic’s Independent Physician Quality Panel, Medtronic offers the following patient management recommendations:
- Physicians should continue routine follow-up sessions at least every three months in accordance with product labeling.
- Physicians should program the audible patient alerts for “Low Battery Voltage ERI” and “Excessive Charge Time EOL” to ON.
- Physicians should replace devices promptly after they reach ERI if the decline in voltage is more rapid than expected.
- Prophylactic replacement of EnTrust ICDs is not recommended.
As of February 11, 2013, there have been 74 confirmed events. No patient deaths have been reported due to this issue. No reports have been made of a failure to deliver high voltage therapy.
|Initial Affected Population||Number of Confirmed Advisory Related Events||Estimated Remaining Active Population||Current Malfunction Rate (confirmed malfunctions over total population)|
|69,000 Worldwide (43,200 United States)||74 Worldwide (56 United States)||30,600 Worldwide (19,400 United States)||0.10% Worldwide (0.12% United States)|