FDA Adverse Event
Malfunction
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 4240758
·
Received November 10, 2014
Report
- Report Number
- 2938836-2014-17744
- Event Type
- Malfunction
- Date Received
- November 10, 2014
- Date of Event
- October 21, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
A PARTIAL LEAD WITH THE CONNECTOR PIN MEASURING 26.2CM WAS RETURNED FOR ANALYSIS. EXTERNAL INSULATION ABRASION WAS NOTED AT 4.4-5.0CM FROM THE CONNECTOR PIN, CONSISTENT WITH LEAD FRICTION TO THE DEVICE CAN. THE ETFE COATING WAS INTACT AT THIS LOCATION.
Additional Manufacturer Narrative · 1
DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING DEVICE CHANGE OUT, AN INSULATION ANOMALY WAS NOTED ON THE PACE/SENSE PORTION OF THE LEAD. THE LEAD WAS CAPPED AND REPLACED. THE PATIENTS CONDITION WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723698 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | SP01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | CD1233-40, 713385 |