FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 1955283
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00304
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- November 18, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT A FEW DAYS POST-IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL WITH A UNSPECIFIC PAIN IN THE BREAST AREA. IT WAS NOTED THAT THE IMPEDANCE AND THRESHOLD INCREASED AND THE SENSING WAS COMPLETELY LOST. AN X-RAY SHOWED THE LEAD PERFORATED. THE LEAD WAS REPOSITIONED AND ALL MEASUREMENTS WERE STABLE. A ECHO WAS PERFORMED AND NO BLOOD WAS NOTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7120Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |