FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1050445
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01426
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 11, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- P880086
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
FINAL ANALYSIS FOUND NO OUTPUT OR TELEMETRY DUE TO BATTERY DEPLETION. THE BATTERY WAS AT END-OF-LIFE (EOL). AFTER REPLACING THE BATTERY THE DEVICE FUNCTIONED NORMALLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR HAD A MAGNET RATE OF 83 PPM AND COULD NOT BE INTERROGATED. AN ATTEMPT TO READ THE ELECTIVE REPLACEMENT INDICATOR (ERI) BIT RESULTED IN AN "OPERATION FAILED" MESSAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5370 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |