FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2243024
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06301
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- July 7, 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 Location
- MD
- 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 ONE DAY POST IMPLANT, THE PHYSICIAN OBSERVED CROSSTALK ON THE VENTRICULAR CHANNEL AFTER AN ATRIAL PACE. IT WAS CONFIRMED THAT THE LEADS DID NOT MOVE. THE PHYSICIAN ELECTED TO PROGRAM THE DEVICE TO VVI MODE. ANALYSIS OF THE DEVICE SUGGESTS A LEAD ISSUE. 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 | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | 2207-36, (B)(4) |