FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 3890301
·
Received January 13, 2014
Report
- Report Number
- 2938836-2014-03694
- Event Type
- Injury
- Date Received
- January 13, 2014
- Date of Event
- October 26, 2012
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CN
- Reporter Occupation
- PHYSICIAN
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 PT EXPERIENCED UNANTICIPATED THERAPY DUE VENTRICULAR LEAD NOISE. THE LEAD WAS CAPPED AND LEFT IN THE BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 31499 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL INC., CRMD | 1570/65 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |