FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4221049
·
Received November 3, 2014
Report
- Report Number
- 2938836-2014-17408
- Event Type
- Injury
- Date Received
- November 3, 2014
- Date of Event
- September 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
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. EVALUATION DESCRIPTION INCLUDED. A SMALL HOLE ON THE PTFE LINER WAS NOTED AT 1.0CM FROM THE DISTAL TIP. THIS MAY HAVE CONTRIBUTED TO THE COMPLAINTS OF UNACCEPTABLE THRESHOLD AND LOW LEAD IMPEDANCE REPORTED FROM THE FIELD. THE CAUSE OF THE SMALL HOLE COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT HIGH CAPTURE THRESHOLD AND A DECREASE IN PACING LEAD IMPEDANCE WERE OBSERVED. AN X-RAY SHOWED THE LEAD HAD DISLODGED. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702292 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |