FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2242561
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06503
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- June 7, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
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 THE PATIENT WAS CHRONICALLY SICK AND WAS ON PALLIATIVE CARE OF THE HOSPITAL. IT WAS NOTED THAT THE PATIENT SUFFERED A STROKE AND DURING EXAMINATION, LEAD PERFORATION WAS OBSERVED. REVIEW OF DEVICE IMAGE NOTED INAPPROPRIATE SHOCKS. THE DEVICE WAS DEACTIVATED UPON PHYSICIAN'S REQUEST ON (B)(6) 2011 AND WAS DECLARED BRAIN DEAD. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT EVENT WAS CAUSED BY DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |