FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3968335
·
Received July 30, 2014
Report
- Report Number
- 2938836-2014-13681
- Event Type
- Injury
- Date Received
- July 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 Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DFT TESTING WAS PERFORMED WITH A RIGHT-SIDED ICD. DFT TESTING AT AN EARLIER DATE WAS NOT SUCCESSFUL AT FIRST BUT EVENTUALLY CONVERTED THE ARRHYTHMIA. DURING A LATER DFT TEST THE PATIENTS ARRHYTHMIA COULD NOT BE CONVERTED. THE DEVICE WAS REIMPLANTED ON THE LEFT SIDE AND THE LEAD WAS EXPLANTED AND REPLACED. A SUBSEQUENT DFT TEST WAS PERFORMED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 445048 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |