FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 2242863
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06254
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 26, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- 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 REPORTED NOISE AND IMPEDANCE MEASUREMENT ANOMALY WERE CONFIRMED IN THE LABORATORY. THE LEAD BODY WAS DAMAGED DUE TO CLAVICULAR CRUSH AT 31.3 CM TO 32.9 CM FROM THE CONNECTOR PIN. ALL CABLE INSULATION CABLES WERE BREACHED AND THE INNER COIL WAS EXPOSED. ALL CABLES ETFE INSULATION WERE ABRADED. THIS ALLOWED CONTACT BETWEEN THE RE CABLES AND THE INNER COIL RESULTING IN NOISE AND OUT-OF-RANGE IMPEDANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE AND OUT-OF-RANGE IMPEDANCE WERE FOUND. AT LEAD REVISION, INSULATION BREAK WAS OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |