FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3911082
·
Received July 2, 2014
Report
- Report Number
- 2938836-2014-12928
- Event Type
- Malfunction
- Date Received
- July 2, 2014
- Date of Event
- May 8, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE REPORTED FIELD EVENT OF A HELIX ANOMALY WAS CONFIRMED IN THE LABORATORY. THE HELIX ACTUATION WAS NOTED TO BE JUMPY DUE TO A BENT HELIX. THE CAUSE OF THE BENT HELIX COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THE HELIX WOULD NOT FULLY EXTEND. THE LEAD WAS REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 385963 | 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 |