FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4130841
·
Received September 30, 2014
Report
- Report Number
- 2938836-2014-16244
- Event Type
- Malfunction
- Date Received
- September 30, 2014
- Date of Event
- September 15, 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
- PA, 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 DURING THE IMPLANT PROCEDURE, POST-PACED T-WAVE OVERSENSING WAS SEEN AFTER THE HV SHOCK DURING DFT TESTING. INITIALLY DEVICE REPROGRAMMING WAS DONE, BUT THE OVERSENSING STILL OCCURRED. THE LEAD WAS REPOSITIONED AND NO FURTHER EPISODES WERE SEEN. THE PATIENT WAS ASYMPTOMATIC AND THE PATIENT CONDITION WAS STABLE THROUGHOUT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 608166 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7121Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |