FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX OPTIM LEAD
MDR report key: 4142985
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05596
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- December 9, 2011
- Manufacturer
- ST. JUDE MEDICAL, CRMD
- Product Code
- DTB
- PMA / PMN Number
- P960030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
ALL INFO WAS PROVIDED BY MFR, NO MEDWATCH FORM WAS RECEIVED. 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. THE LEAD WAS CLINICALLY RESOLVED BY REPROGRAMMING. THE LEAD REMAINED IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31936 | ISOFLEX OPTIM LEAD | PERMANENT PACEMAKER ELECTRODE | DTB | ST. JUDE MEDICAL, CRMD | 1944/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |