FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4153701
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16525
- Event Type
- Injury
- 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
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER RECEIVING INAPPROPRIATE THERAPY DUE TO OVERSENSING. A MICRO DISLODGEMENT WAS NOTED VIA X-RAY. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS NOT SUCCESSFUL. THE PROCEDURE WENT WELL. PATIENT WAS DISCHARGED THE NEXT DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632012 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |