FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION
MDR report key: 3791162
·
Received May 5, 2014
Report
- Report Number
- 2938836-2014-10427
- Event Type
- Injury
- Date Received
- May 5, 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 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 PRESENTED IN-CLINIC AFTER RECEIVING MULTIPLE INAPPROPRIATE SHOCKS. DECREASED SENSING WAS OBSERVED AND LEAD DISLODGEMENT WAS CONFIRMED VIA X-RAY. NO ADVERSE CONSEQUENCES FOR THE PATIENT WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 268367 | DURATA STS OPTIM PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7170/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |