FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 4130820
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16257
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- August 20, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0458
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WAS RETURNED IN TWO SEGMENTS FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 12.5-12.8CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. EXTERNAL INSULATION ABRASION WAS NOTED AT 30.9-31.2CM FROM THE DISTAL TIP, CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. THE ETFE COATING WAS INTACT AT THESE LOCATIONS.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE REPLACEMENT FOR NORMAL ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS STABLE AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607483 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |