FDA Adverse Event
Injury
Summary report: N
IDENTITY DR
MDR report key: 1050532
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01503
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 26, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC
- 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 THE PULSE GENERATOR WAS IN BACK-UP MODE. SEVERAL ATTEMPTS TO PERFORM A DOWNLOAD FAILED. INTERROGATION OF THE DEVICE WAS UNSUCCESSFUL. IN OCTOBER 2007, THE MEASURED BATTERY DATA WAS 2.67 V, 15UA, 7.5 KOHMS AND ABOUT SEVEN MONTHS REMAINING LONGEVITY. THE DEVICE WAS SUBSEQUENTLY 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 |