FDA Adverse Event
Injury
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 1955220
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00543
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 18, 2010
- 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, EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS NOTED ON THE R-WAVES BUT NO INAPPROPRIATE SHOCKS WERE DELIVERED. WHEN THE I-S 1 LEAD WAS REMOVED FROM THE DEVICE, A SMALL CRACK WAS OBSERVED BELOW THE CONNECTOR PIN. THE LEAD WAS PARTIALLY CAPPED AND A NEW SENSE/PACE LEAD WAS ADDED. THE DEFIB PORTION OF THE LEAD REMAINS ACTIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | SP01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Required Intervention |