FDA Adverse Event
Malfunction
Summary report: N
DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR
MDR report key: 2984317
·
Received February 28, 2013
Report
- Report Number
- 2938836-2013-00523
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Date of Event
- January 7, 2013
- 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 DURING FOLLOW UP, HIGH IMPEDANCE AND HIGH THRESHOLD, NOISE, SENSING ANOMALIES AND INAPPROPRIATE VF DETECTIONS WERE OBSERVED. LEAD ANOMALY IS SUSPECTED. LEAD REMAINS IMPLANTED AS THE PATIENT IS HIGH RISK AND THE PHYSICIAN DOES NOT WANT TO REPLACE THE LEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 87630 | DURATA STS OPTIM PASSIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7170Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |