FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 4173901
·
Received October 15, 2014
Report
- Report Number
- 2938836-2014-16731
- Event Type
- Injury
- Date Received
- October 15, 2014
- Date of Event
- September 8, 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
- NJ, 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 A SYMPTOMATIC PATIENT PRESENTED IN THE EMERGENCY ROOM AFTER EXPERIENCING A SYNCOPAL EPISODE CAUSING HIM TO FALL AND CUT HIS HEAD. LEAD EXHIBITED NOISE EPISODES. THE NOISE WAS REPRODUCED WITH POCKET MANIPULATION AND ISOMETRICS. PATIENT HAD REPORTED COMPLAINT OF DIZZINESS INTERMITTENTLY SINCE THE LAST DEVICE CHANGE OUT. THE LEAD WAS PARTIALLY CAPPED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 655766 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC., CRMD | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |