FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR
MDR report key: 3220249
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04335
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- April 16, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT PRESENTED TO THE OFFICE FOR A PROGRAMMING VISIT. INCREASED RV PACING THRESHOLD AND DECREASED SENSING WERE NOTED. A CHEST X-RAY CONFIRMED LEAD DISLODGEMENT. THE LEAD WAS EXPLANTED AND REPLACED.
Description of Event or Problem · 1
NEW INFORMATION RECEIVED NOTES THAT THE DISLODGEMENT WAS BELIEVED TO BE DUE TO A HELIX ANOMALY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320583 | DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Required Intervention |