FDA Adverse Event
Malfunction
Summary report: N
IDENTITY DR
MDR report key: 1073370
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02159
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 1, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- Z2977
- 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 - COMPANY REPRESENTATIVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THREE ATTEMPTS TO PERFORM THE VENTRI- CULAR AUTOCAPTURE SETUP TEST WERE UNSUCCESSFUL, EACH TIME GIVING A TELEMETRY ISSUE ERROR. THE MEASURED BATTERY DATA WAS 2.68 V, 9 UA, 15.1 KOHMS WITH AN ESTIMATED 0.5 YEARS RE- MAINING. ADDITIONAL TESTING COULD NOT BE RUN SUCCESSFULLY AND FURTHER TROUBLESHOOTING WAS DECLINED BECAUSE OF TIME CONSTRAINTS.
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 |