Marquis Family Device Update
July 2005
This is an update to the February 2005 letter regarding the Medtronic Marquis family of ICD and CRT-D devices having batteries manufactured prior to December 2003 that may experience rapid battery depletion due to a specific internal battery shorting mechanism.
Battery Shorting Performance Status
The Marquis Family device performance related to the battery shorting mechanism continues to be within Medtronic’s engineering projections and expectations. As of June 15, 2005, seventeen (17) devices out of approximately 87,000 worldwide (0.02% incidence), have been confirmed as having the internal battery shorting mechanism. Twelve (12) of these devices were returned from the US. There have been no reported serious injuries or deaths due to this issue.
Clinical Observations
Eleven (11) of the seventeen (17) returns have been identified via either regularly scheduled follow-up or during a non-device related hospital visit, five (5) by patients reporting warmth in the ICD pocket and (1) for return of bradycardia symptoms.
Performance in the Second Half of Device Life
Consistent with previous Medtronic projections, the majority of these devices returned from the field with the battery shorting mechanism are estimated to have shorted in the second half of device life. Twelve (12) of the seventeen (17) occurred in the second half of device life. Of these, nine (9) occurred in the last quarter of device life, and six (6) of these have occurred in the last 10% of device life. Medtronic’s follow-up recommendations remain unchanged from our February communication.
- Conduct quarterly (i.e., every three 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 AlertTM 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 that most shorts will occur rapidly and will not be detected by this feature.
- Provide a handheld magnet to patients to check device status and program the Low Battery Voltage ERI Patient AlertTM 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.
Overall Marquis Family Performance
The latest edition of the Medtronic CRM Product Performance Report includes specific information pertaining to this battery shorting mechanism. The complete report is available online at www.CRMPPR.medtronic.com. The next update regarding these devices will be provided in the Second Edition of the 2005 CRM Product Performance Report, slated for publication in December 2005.
Please contact Released Product Quality at 1-800-328-2518, extension 48644 or contact Technical Services at 1-800-723-4636 should you have any comments or questions.