FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 5191030
·
Received October 30, 2015
Report
- Report Number
- 3010215456-2015-29779
- Event Type
- Injury
- Date Received
- October 30, 2015
- Date of Event
- September 24, 2015
- Report Date
- September 24, 2015
- Manufacturer
- ST. JUDE MEDICAL, INC. (CRM-KISTA)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD HAD DISLODGED. THE SENSING DROPPED SUDDENLY AND PATIENT RECEIVED AN INADEQUATE SHOCK. THE LEAD WAS REPLACED. PATIENT WAS IN A STABLE CONDITION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 723646 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC. (CRM-KISTA) | 7122/65 | 2912467 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |