FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3872942
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11784
- Event Type
- Injury
- Date Received
- June 13, 2014
- Date of Event
- April 30, 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
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE WAS OBSERVED VIA REMOTE TRANSMISSION. REVIEW OF THE TRENDS SHOWED A GRADUAL INCREASE IN HIGH VOLTAGE LEAD IMPEDANCE AND PACING LEAD IMPEDANCE. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS FINE AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349180 | DURATA STS OPTIM PASSIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |