FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 4193311
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05571
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- February 27, 2012
- Manufacturer
- ST. JUDE MEDICAL, INC, CRMD
- Product Code
- NVN
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, 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. EVALUATION DESCRIPTION: THE INSULATION DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED UNACCEPTABLE THRESHOLDS DURING IMPLANT. THE LEAD WAS NOT IMPLANTED. PATIENT CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31331 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE, NVN | NVN | ST. JUDE MEDICAL, INC, CRMD | 1642T/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |