FDA Adverse Event
Malfunction
Summary report: N
SPL LEAD, TRANSVENOUS
MDR report key: 3801392
·
Received May 8, 2014
Report
- Report Number
- 2938836-2014-10948
- Event Type
- Malfunction
- Date Received
- May 8, 2014
- Date of Event
- February 21, 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
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED DURING A DEVICE CHANGE-OUT FOR NORMAL ERI, WHEN THE LEAD WAS EXPOSED, IT APPEARED IT HAD BEEN PREVIOUSLY REPAIRED. FRACTURE WAS OBSERVED. TESTING WITH AN ANALYZER REVEALED HIGH PACING IMPEDANCE AND LOW HIGH VOLTAGE IMPEDANCE. THE SYSTEM WAS EXPLANTED AND THE PATIENT WAS SENT HOME IN STABLE CONDITION WITH A LIFE VEST PENDING NEW IMPLANT SURGERY. A WEEK LATER, A NEW SYSTEM WAS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 279326 | SPL LEAD, TRANSVENOUS | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | SP02 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | 1056K/86 DJ20177 |