FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4221090
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17387
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- August 19, 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
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 WAS HOSPITALIZED AFTER RECEIVING INAPPROPRIATE HIGH VOLTAGE THERAPY DUE TO OVERSENSING OF NOISE. INSULATION DAMAGE AND SUSPECTED FRACTURE WERE ALSO NOTED. THE NOISE WAS REPRODUCIBLE IN CLINIC. THE LEAD WAS CAPPED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702358 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |