FDA Adverse Event
Injury
Summary report: N
IDENTITY XL DR
MDR report key: 1223025
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03239
- 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
- GA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED FOR FOLLOW-UP FEELING FATIGUED. THE PULSE GENERATOR WAS IN BACKUP VVI, AND PATIENT'S PRESENTING RHYTHM WAS 67.5 PULSES PER MINUTE VVI PACED. THE MESSAGE "OPERATION FAILED" DISPLAYED WHEN TRYING TO CHECK HISTORICAL IMPEDANCES. A USER DOWNLOAD WAS UNSUCCESSFUL. THE DEVICE WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY XL DR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5376 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |