FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4153675
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16450
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- August 12, 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
- AZ, 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 THAT THE PATIENT PRESENTED TO CLINIC AFTER RECEIVING HIGH VOLTAGE THERAPY WITH LOW, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE. THE PATIENT WILL BE CLOSELY MONITORED WITH ROUTINE FOLLOW-UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631852 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/52 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 61 YR |