FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4130832
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16173
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- August 26, 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
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE. THE LEAD WAS OTHERWISE NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A DEVICE CHANGE-OUT DUE TO NORMAL ERI, LEAD INSULATION ANOMALY AND OVERSENSING WERE OBSERVED. THE LEAD WAS EXPLANTED AND REPLACED. PATIENT CONDITION WAS GOOD AFTER EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 607487 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |