FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4153677
·
Received October 8, 2014
Report
- Report Number
- 2938836-2014-16425
- Event Type
- Malfunction
- Date Received
- October 8, 2014
- Date of Event
- September 5, 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
- WI, 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 NON SUSTAINED VENTRICULAR OVERSENSING EPISODES WERE OBSERVED VIA MERLIN.NET TRANSMISSION. THE ICD WAS REPROGRAMMED AND NO FURTHER EPISODES HAVE BEEN NOTED. LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 632246 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7120Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | (B)(4) |