FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 4153716
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16493
- Event Type
- Injury
- Date Received
- October 8, 2014
- Date of Event
- September 15, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 11.2CM WAS RETURNED FOR ANALYSIS. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT LEAD WAS CAPPED AND REPLACED DUE TO INSULATION ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632040 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1571/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |