FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4153629
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16479
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 10, 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 Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT RISING CAPTURE THRESHOLD AND HIGH PACING LEAD IMPEDANCE WAS OBSERVED. FRACTURE WAS SUSPECTED. LEAD WAS CAPPED AND REPLACED DURING DEVICE CHANGEOUT DUE TO NORMAL ERI. THE PATIENTS CONDITION WAS FINE AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 631683 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | 1156T/86, (B)(4), 1458Q/75, (B)(4) |