FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION LEAD
MDR report key: 4091546
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-04859
- Event Type
- Malfunction
- Date Received
- January 13, 2014
- Date of Event
- November 8, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
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 NOISE WAS OBSERVED ON THE LEAD. THE PATIENT WOULD CONTINUE TO BE MONITORED DURING F/U VISITS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 23264 | RIATA ST PASSIVE FIXATION LEAD | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL INC., CRMD | 7040/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR |