FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3447738
·
Received November 4, 2013
Report
- Report Number
- 2938836-2013-07956
- Event Type
- Injury
- Date Received
- November 4, 2013
- Date of Event
- August 20, 2013
- 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
- IA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING ROUTINE IMPLANT, WHEN ARRHYTHMIA WAS INDUCED, THE DEVICE FAILED TO RESCUE THE PATIENT. THE DEVICE DELIVERED THE FIRST SHOCK, BUT FAILED TO DELIVER ALL SUBSEQUENT SHOCKS. AFTER THE PATIENT WAS RESCUED, AN ALERT FOR LOW HV LEAD IMPEDANCE WAS RECEIVED. DEVICE AND LEAD WERE NOT IMPLANTED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 566607 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | (B)(4), 7053241 |