FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4221129
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17424
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- August 22, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. A PARTIAL LEAD WAS RETURNED IN FOUR SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASIONS WERE NOTED AT 0.4-0.5CM AND 3.2-3.3CM FROM THE PROXIMAL CUT END OF THE MIDDLE SECTION OF THE LEAD, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS CAPPED AND REPLACED DUE TO AN INSULATION ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702969 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |