FDA Adverse Event
Malfunction
Summary report: N
ACCENT SR RF OUS
MDR report key: 2905224
·
Received January 9, 2013
Report
- Report Number
- 2017865-2013-00816
- Event Type
- Malfunction
- Date Received
- January 9, 2013
- Date of Event
- November 21, 2012
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND THAT THE RF MODULE WAS SUSPECTED TO BE THE CAUSE OF THE HIGH CURRENT DRAIN AND PREMATURE BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR EXHIBITED PREMATURE BATTERY DEPLETION. IN (B)(6)2011 THE DEVICE DISPLAYED OVER 10 YEARS OF EXPECTED LONGEVITY. THE PT HAD NOT BEEN TO THE CLINIC IN OVER A YEAR. THE DEVICE INTERROGATION SHOWED THE DEVICE HAD REACHED ERI IN (B)(6) 2011. THE DEVICE WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 12207 | ACCENT SR RF OUS | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | PM1210 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 92 YR |