FDA Adverse Event
Injury
Summary report: N
IDENTITY SR
MDR report key: 1223868
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03427
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 30, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DXY
- PMA / PMN Number
- PMAP880086
- Removal / Correction Number
- Z2977
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- 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 DATA COULD NOT BE READ UPON INTERROGATION OF THE PULSE GENERATOR. TELEMETRY ERRORS WERE NOTED UPON ATTEMPTS TO REINTERROGATE. THE DEVICE WAS REPLACED DUE TO NORMAL ELECTIVE REPLACEMENT INDICATOR. IT WAS NOTED THAT THE PATIENT WAS PACEMAKER DEPENDENT.
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 |