FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 2242556
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06436
- Event Type
- Injury
- Date Received
- September 10, 2011
- Date of Event
- April 6, 2011
- 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 THRESHOLDS HAD INCREASED AND THE R-WAVES HAD DECREASED. THE LEAD WAS EXPLANTED AND REPLACED WHEN REPOSITIONING WAS UNSUCCESSFUL.
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 | 7121Q/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | Required Intervention |