FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2984387
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00372
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED THE LEAD WAS RETURNED CUT IN TWO SEGMENTS. EXTERNAL INSULATION ABRASION WAS FOUND ON THE IS-1 CONNECTOR LEG AT 6.9-7.7 CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE SENSING COIL WAS VISIBLE AND COULD COME IN CONTACT WITH THE ICD CAN AND CAUSE THE REPORTED ISSUE FROM THE FIELD.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO NOISE ON THE RV CHANNEL, WHICH WAS OBSERVED VIA IEGM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88169 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |