Potential Premature Battery Depletion Due to Battery Short
Marquis 7274, 7230 Maximo 7278, 7232 InSync 7277, 7289, 7279, 7285
Original Date of Advisory:
The specific subset of Marquis family ICD and CRT-D devices having batteries manufactured prior to December 2003 is affected. Devices manufactured with batteries produced after December 2003 are not affected. You may use the "Search for Information by Serial Number" tool on this web page to determine if a specific device is affected.
Medtronic Marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 may experience rapid battery depletion due to a specific internal battery short mechanism. Battery design changes were implemented in December 2003 that eliminate the possibility of this internal shorting mechanism.
Highly accelerated bench testing indicated the rate of this shorting mechanism may increase as the battery is depleted. As of February 2005, the rate of shorting was approximately 1 in 10,000 (0.01%); bench test data indicated the rate may increase to between 0.2% and 1.5% over the second half of device life.
No provocative testing can predict which of these devices will experience this issue. Once a short occurs, battery depletion can take place within a few hours to a few days. After depletion the device ceases to function. It is also possible that as the battery depletes quickly, patients may experience temporary warmth in the area surrounding the ICD.
Patient Management Recommendations
We recommend you consider the following patient management options:
- Conduct quarterly (i.e., every 3 months) follow-up procedures
- Inform patients that should they experience warmth in the area surrounding the ICD to seek follow-up care promptly
- Program Low Battery Voltage ERI Patient Alert to “On-High.” This will result in an audible, alternating tone in the limited circumstances where a battery depletes slowly over a number of days. Data indicates most shorts will occur rapidly and will not be detected by this feature.
- Provide a hand-held magnet to patients to check device status and program the Low Battery Voltage ERI Patient Alert to “On-High.” Device operation may be monitored periodically (e.g., daily) by patients placing the magnet over the device for 1-2 seconds. If the device is functional, a steady tone will sound for approximately 20 seconds. If no tone is heard, follow-up care should be sought promptly.
The Marquis Family device performance related to the battery shorting mechanism continues to be within Medtronic’s engineering projections. As of January 31, 2014, 192 Marquis Family devices have been confirmed as having this internal battery shorting mechanism. One hundred fifteen (116) of these devices were returned from the United States.
Out of the initial advisory population of 87,000 worldwide, approximately 2,200 remain implanted. Approximately 1,900 of these are in the United States. The Patient Management Recommendations set forth in the advisory remain unchanged.
|Initial Affected Population||Number of Confirmed Advisory Related Events||Estimated Remaining Active Population||Current Malfunction Rate (confirmed malfunctions over total population)||Predicted Malfunction Rate Over the Remaining Life of the Devices Still Implanted|
87,000 Worldwide (76,000 United States)
192 Worldwide (116 United States)
2,200 Worldwide (1,900 United States)
0.22% Worldwide (0.15% United States)
|Consistent with Medtronic projections, the observed rate of shorting may be between 0.2% and 1.5% over the second half of device life.|