FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3872956
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11836
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- May 20, 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
Description of Event or Problem · 1
IT WAS REPORTED THAT AN EPISODE OF VF WAS RECORDED DUE TO NOISE. AN INCREASE IN IMPEDANCE WAS ALSO NOTED. LEAD WAS EXPLANTED, EXCEPT FOR THE TIP. THE PATIENTS CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349520 | DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |