FDA Adverse Event
Malfunction
Summary report: N
IDENTITY ADX DR
MDR report key: 1223729
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03213
- Event Type
- Malfunction
- Date Received
- November 10, 2008
- Date of Event
- August 13, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- FL
- 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 INTERROGATION NO INTRACARDIAC ELECTROGRAM (IEGM) WAS AVAILABLE. REBOOTING AND REINTERROGATING WAS ATTEMPTED MULTIPLE TIMES. NO STORED ELECTROGRAMS WERE AVAILABLE. THE PATIENT CHART FROM SIX MONTHS BEFORE SHOWED THE SAME ISSUE. MULTIPLE PROGRAMMERS AND WANDS AS WELL AS TWO ATTEMPTS AT NORMAL TROUBLESHOOTING METHODS WERE UNSUCCESSFUL. THE SYSTEM WAS TO REMAIN IMPLANTED AND BE FOLLOWED NORMALLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY ADX DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5380 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |