FDA Adverse Event
Malfunction
Summary report: N
ISOFLEX S
MDR report key: 4193308
·
Received January 13, 2014
Report
- Report Number
- 2017865-2014-05566
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- March 6, 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 FIELD COMPLAINT OF A TINE ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. VISUAL INSPECTION REVEALED NO ANOMALIES ON THE LEAD, INCLUDING THE TINES. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. NO ANOMALY WAS FOUND. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TINES OF THE LEAD EXHIBITED AN ANOMALY. THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31330 | ISOFLEX S | PERMANENT PACEMAKER ELECTRODE, NVN | NVN | ST. JUDE MEDICAL, INC., CRMD | 1642T/52 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR |