FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1895721
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04572
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- August 18, 2010
- 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
- NY
- 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 PACE/SENSE PORTION OF THE LEAD WAS WORSENING DURING THE LAST FEW INTERROGATIONS. THE THRESHOLD WAS INCREASING AND SHOWED LOSS OF CAPTURE. THE PHYSICIAN STATED THAT THE SENSING HAD BEEN HISTORICALLY POOR. X-RAY WAS INCONCLUSIVE. THE PHYSICIAN OPTED TO MONITOR THE PATIENT.
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 | 88 YR |