FDA Adverse Event
Injury
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 1831125
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03220
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 14, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- 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 DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. ONLY A PARTIAL LEAD WAS RETURNED, MEASURING 18.7 CM FROM THE CONNECTOR PIN.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE INAPPROPRIATE SHOCKS WERE DELIVERED CONSECUTIVELY DUE TO OVERSENSING. THE LEAD WAS EXPLANTED. AT EXPLANT, LEAD FRACTURE WAS OBSERVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1572/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |