FDA Adverse Event
Malfunction
Summary report: N
IDENTITY SR
MDR report key: 1896384
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-05260
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 16, 2010
- 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 Location
- TX
- 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 THE PULSE GENERATOR EXHIBITED EXCESSIVE BATTERY DRAIN. ON (B)(6) 2010, BATTERY DATA WAS 2.71 V, 7 UA AND 3.7 KOHMS WITH AN ESTIMATED 2.1 TO 3.2 YEARS REMAINING LONGEVITY TO ELECTIVE REPLACEMENT INDICATOR (ERI). ON (B)(6) 2010, BATTERY DATA WAS 2.74 V, 7 UA AND 24.8 KOHMS WITH AN ESTIMATED 1 TO 3 MONTHS TO ERI. NO CHANGES HAD BEEN MADE SINCE FEBRUARY. THE NON-PACEMAKER DEPENDENT PATIENT WOULD BE MONITORED.
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 | 86 YR |