FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 4032453
·
Received August 25, 2014
Report
- Report Number
- 2938836-2014-14788
- Event Type
- Injury
- Date Received
- August 25, 2014
- Date of Event
- July 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
EXTERNAL INSULATION ABRASION WAS NOTED AT 12.2-12.6CM AND 12.5-12.7CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. EXTERNAL INSULATION ABRASION WAS NOTED AT 14.6-16.3CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS ABRADED AT THIS LOCATION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE ASYMPTOMATIC PATIENT PRESENTED FOR DEVICE CHANGE OUT DUE TO NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS EXPLANTED AND REPLACED. NO COMPLICATIONS WERE REPORTED AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 514807 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |