FDA Adverse Event
Injury
Summary report: N
IDENTITY ADX DR
MDR report key: 1050541
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01512
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 31, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- 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 INTERROGATE WERE UNSUCCESSFUL. THE MEASURED BATTERY DATA WAS 2.66 V, 26 UA, 10 KOHMS IN JANUARY 2008. THE DEVICE WAS SUBSEQUENTLY REPLACED.
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 | Required Intervention |