FDA Adverse Event
Injury
Summary report: N
IDENTITY SR
MDR report key: 1223026
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03240
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 20, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PULSE GENERATOR COULD NOT BE INTERROGATED ATTEMPTS WERE MADE WITH THREE DIFFERENT PROGRAMMERS. A SOFTWARE DOWNLOAD AND INTERROGATION IN A DIFFERENT ROOM WERE ALSO UNSUCCESSFUL. AS THE PATIENT WAS PACEMAKER DEPENDENT, THE PHYSICIAN ELECTED TO REPLACE THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | IDENTITY SR | IMPLANTABLE PACEMAKER PULSE GENERATOR | DXY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 5172 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |