FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 3057413
·
Received August 15, 2006
Report
- Report Number
- 2938836-2006-00833
- Event Type
- Injury
- Date Received
- August 15, 2006
- Date of Event
- July 24, 2006
- Report Date
- July 24, 2006
- Manufacturer
- ST. JUDE MEDICAL INC., CRMD
- Product Code
- LWS
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IN IT'S ENTIRETY WAS COMPLETED SOLELY BY ST. JUDE MEDICAL, INC., CRMD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS REPOSITIONED DUE TO HIGH THRESHOLDS. IT WAS ALSO REPORTED THAT AFTER NUMEROUS LEAD REPOSITIONS, THE HELIX WOULD NOT EXTEND. AS A RESULT, THE LEAD WAS EXPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST. JUDE MEDICAL INC., CRMD | 7001/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention | (B)(4) |