FDA Adverse Event
Malfunction
Summary report: N
AV PLUS DX BIFURCATED BIPOLAR
MDR report key: 4121539
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-07736
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- April 10, 2012
- Manufacturer
- ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI
- Product Code
- DTB
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THIS HISTORICAL COMPLAINT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF COMPLAINT FILES IN RESPONSE TO A RECENT FDA INSPECTION. THERE IS NO CHANGE TO THE ACTUAL PERFORMANCE OF THE PRODUCT AND THIS REPORT ONLY REPRESENTS AN ENHANCEMENT TO THE REPORTING CRITERIA GOING FORWARD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ATRIAL LEAD EXHIBITED NOISE AND LOW IMPEDANCE. IT WAS RESOLVED BY REPROGRAMMING. LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 32747 | AV PLUS DX BIFURCATED BIPOLAR | DTB | ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI | 1368/58 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR |