FDA Adverse Event
Malfunction
Summary report: N
IDENTITY SR
MDR report key: 2014060
·
Received March 10, 2011
Report
- Report Number
- 2017865-2011-01725
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 10, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- Z2977
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A TWELVE MONTH PULSE GENERATOR FOLLOW-UP, BATTERY LONGEVITY WAS FOUND TO BE 0.25 YEARS WITH A BATTERY VOLTAGE OF 2.64 V. AT THE PREVIOUS FOLLOW-UP, THE ESTIMATED BATTERY LONGEVITY WAS 2-2 .5 YEARS. REPLACEMENT OF THE PULSE GENERATOR WAS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5172 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 98 YR |