FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2083842
·
Received May 10, 2011
Report
- Report Number
- 2017865-2011-03592
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- January 4, 2011
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- 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 PRESENTED TO THE CLINIC DUE TO RECEIVING A SHOCK. UPON INTERROGATION, THE DEVICE WAS FOUND IN BACKUP VVI MODE. NO EPISODES, ALERTS OR EGMS COULD BE RETRIEVED FROM THE DEVICE. THE PATIENT STATED WHILE PREPARING DINNER HE BECAME LIGHT HEADED AND FELT VIBRATIONS AND A SHOCK. THE DEVICE WAS EXPLANTED AND REPLACED. FAILURE OBSERVED DURING ICD ANALYSIS. IT IS SUSPECTED THAT THE LEAD MIGHT BE DAMAGED. THE LEAD REMAINS IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | 2207-36, (B)(4) |