FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 3872934
·
Received June 13, 2014
Report
- Report Number
- 2938836-2014-11798
- Event Type
- Malfunction
- Date Received
- June 13, 2014
- Date of Event
- April 18, 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT AN ASYMPTOMATIC PATIENT PRESENTED FOR A ROUTINE FOLLOW-UP. HIGH, OUT OF RANGE, HIGH VOLTAGE LEAD IMPEDANCE MEASUREMENTS WERE OBSERVED FOR VECTORS INCLUDING THE SVC COIL. ISOMETRICS AND POCKET MANIPULATION WAS PERFORMED AND NOISE WAS NOT EVIDENT. THE PATIENT WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 349498 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |