FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 2984289
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00485
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 4, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED. DEVICE EVALUATION ANTICIPATED BUT NOT YET BEGUN.
Additional Manufacturer Narrative · 1
ANALYSIS WAS NORMAL. NO ANOMALY WAS FOUND. THE LEAD EXHIBITED NORMAL ELECTRICAL CHARACTERISTICS.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PACING THRESHOLD ABRUPTLY INCREASED AFTER 8 MONTHS OF IMPLANT. DURING LEAD REVISION, IT WAS OBSERVED THAT THE POCKET WAS HEAVILY ENCAPSULATED WITH SCAR TISSUE. EXIT BLOCK SUSPECTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 85927 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR |