FDA Adverse Event
Malfunction
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 3911108
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-12941
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- May 19, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 26.0CM WAS RETURNED FOR ANALYSIS. THE PORTION OF THE LEAD THAT WAS RETURNED WAS OTHERWISE NORMAL. WITHOUT RETURN OF THE ENTIRE LEAD, A COMPLETE ANALYSIS COULD NOT BE PERFORMED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE ASYMPTOMATIC PATIENT PRESENTED FOR ROUTINE GENERATOR REPLACEMENT. UPON OPENING THE POCKET, INSULATION ABRASION ON THE PACE/SENSE PORTION EXPOSING THE CONDUCTORS WERE OBSERVED. NO ELECTRICAL ANOMALIES WERE DETECTED. THE LEAD WAS CAPPED AND LEFT IN SITU AND A NEW LEAD WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385785 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | SP01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |