FDA Adverse Event
Injury
Summary report: N
AV PLUS DX BIFURCATED BIPOLAR
MDR report key: 1073251
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02050
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- March 18, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- DTB
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
FINAL ANALYSIS REVEALED ONE OF FOUR TINES MISSING. THERE WAS NO INDICATION THAT THE DAMAGE ON THE LEAD WAS PRODUCTION RELATED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE FOLLOW UP NO TESTS COULD BE PERFORMED. DURING A REPOSITIONING PROCEDURE, TESTS COULD NOT BE PERFORMED WITH THE PSA SYSTEM. THE LEAD WAS REMOVED, WHICH REVEALED THAT IT WAS DAMAGE.D.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AV PLUS DX BIFURCATED BIPOLAR | PERMANENT PACEMAKER ELECTRODE | DTB | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1368/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |