FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1223027
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03241
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 18, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- NA
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT MEASURED DATA COULD NOT BE OBTAINED UPON INTERROGATION. THE PULSE GENERATOR WAS LAST INTERROGATED IN 2008, AT WHICH TIME THE BATTERY DATA WAS 2.71 V, 9 UA, AND 8.5 K, WITH AN ESTIMATED ONE YEAR REMAINING TO ELECTIVE REPLACEMENT INDICATOR. WHEN IT WAS ATTEMPTED TO PROGRAM THE DEVICE TO VVI, TELEMETRY WAS LOST AND FURTHER TROUBLESHOOTING WAS DISCONTINUED. THE DEVICE WAS REPLACED.
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 |