FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1223166
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03730
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 4, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE LEAD WAS RETURNED IN TWO PIECES AND WAS CUT AT 11 CM FROM THE CONNECTOR PIN AS RECEIVED. THE TWO PORTIONS OF THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS. FURTHER ANALYSIS FOUND AN ABRASION ON THE OUTER INSULATION AT 15 CM TO 17 CM FROM THE HELIX END. THE ABRASION FOUND IS CONSISTENT WITH THAT CAUSED BY FRICTION WITH THE ICD CAN.
Additional Manufacturer Narrative · 1
NA
Description of Event or Problem · 1
THE LEAD WAS EXPLANTED DUE TO A SUSPECTED MALFUNCTION. NO FURTHER INFORMATION PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |