FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 4900910
·
Received July 9, 2015
Report
- Report Number
- 3010215456-2015-27948
- Event Type
- Injury
- Date Received
- July 9, 2015
- Date of Event
- April 10, 2015
- Report Date
- April 10, 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
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW UP, LOW SENSING AND NO CAPTURE WERE OBSERVED. THE LEAD WAS REPLACED AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447425 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC. (CRM-KISTA) | 7122Q/58 | 4864001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |