FDA Adverse Event
Injury
Summary report: N
TVL LEAD, RIGHT VENTRICULAR
MDR report key: 1831091
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03622
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- March 16, 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. VISUAL ANALYSIS OF THE LEAD REVEALED AN INSULATION ABRASION AT 8 CM FROM THE CONNECTOR PIN. THE LEAD ABRASION IS CONSISTENT WITH THAT PRODUCED BY FRICTION WITH THE ICD CAN.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD WAS EXPLANTED DUE TO DAMAGE TO THE ICD'S HV OUTPUT CIRCUITRY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TVL LEAD, RIGHT VENTRICULAR | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | RV06 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Required Intervention |