FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4173947
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16649
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 15, 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.ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT NO SENSING AND HIGH CAPTURE THRESHOLD WERE OBSERVED. X-RAY REVEALED THE LEAD HAD DISLODGED. LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL. PATIENT CONDITION WAS GOOD DURING AND AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655340 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Required Intervention |