Advisories
7274 Marquis DR |
7277 InSync Marquis |
| Original Date of Advisory: February 2005 | |
Potential Premature Battery Depletion Due to Battery Short
Product
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. Specific model and serial numbers of affected devices are available online at http://MarquisSNList.medtronic.com.
Advisory
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.
Status Update
The Marquis Family device performance related to the battery shorting mechanism continues to be within Medtronic’s engineering projections. As of January 31, 2009, 129 Marquis Family devices have been confirmed as having this internal battery shorting mechanism. Sixty-six (66) of these devices were returned from the United States.
Of the 129 returns, 40 have been identified by patients reporting warmth in the ICD pocket, 44 by a regularly scheduled follow-up or during a non–device-related hospital visit, 17 by hand-held magnet test or CareLink attempt, nine by return of bradycardia symptoms, five by the Patient Alert sounding, and 14 unknown.
Implant duration for the 129 devices ranged between 11 to 70 months, with an average of 41 months.
Consistent with Medtronic projections, the observed rate of shorting is higher in the second half of device life than in the first half of device life. Of the devices that have exhibited shorting in the last half of device life, 48% occurred in the last quarter of device life and 31% in the last 10% of device life.
Out of the initial advisory population of 87,000 worldwide, approximately 23,900 remain implanted. Approximately 20,700 of these are in the United States.
The Patient Management Recommendations set forth in the advisory remain unchanged.
Warranty
All Marquis devices are subject to a Limited Warranty. Devices returned to Medtronic and determined to be malfunctioning will be replaced or credited in accordance with the warranty terms. In addition, for devices subject to the Marquis advisory, should a physician decide to replace a device for a patient who is pacemaker dependent or who receives frequent VT/VF therapy, Medtronic will, upon receipt of a written statement from the physician setting forth the basis for early replacement of the device, provide a replacement device at no cost.