FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3854713
·
Received June 6, 2014
Report
- Report Number
- 2938836-2014-11618
- Event Type
- Injury
- Date Received
- June 6, 2014
- Date of Event
- April 1, 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
A FRACTURE OF THE INNER COIL WAS NOTED AT 18.1CM FROM THE CONNECTOR PIN CONSISTENT WITH FATIGUE. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATIONS FROM THE FIELD OF HIGH PACING LEAD IMPEDANCE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD EXHIBITED HIGH PACING LEAD IMPEDANCE, HIGH CAPTURE THRESHOLD, AND NOISE. LEAD FRACTURE WAS SUSPECTED. THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENT WAS IN GOOD CONDITION FOLLOWING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331096 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |