FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 3854687
·
Received June 6, 2014
Report
- Report Number
- 2938836-2014-11484
- Event Type
- Injury
- Date Received
- June 6, 2014
- Date of Event
- May 9, 2014
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STATED HE HAD RECEIVED MULTIPLE SHOCKS. DEVICE INTERROGATION REVEALED FAR-FIELD P-WAVE OVERSENSING. X-RAY IMAGE SHOWED THAT THE LEAD WAS DISLODGED. WHEN REPOSITIONING WAS UNSUCCESSFUL, THE LEAD WAS EXPLANTED AND REPLACED. THE PATIENTS MEDICAL CONDITION WAS GOOD AFTER THE EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331023 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |