FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 1954970
·
Received January 10, 2011
Report
- Report Number
- 2017865-2011-00408
- Event Type
- Injury
- Date Received
- January 10, 2011
- Date of Event
- October 26, 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
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE, THE PATIENT FELT A CONTINUOUS MODERATE PAIN IN THE THORAX. LOSS OF CAPTURE WAS OBSERVED. ON THE RX IMAGE, THE TIP OF THE LEAD WAS FOUND TO BE IN THE PERICARDIUM. THE PHYSICIAN REMOVED THE LEAD FROM THE VENTRICLE AND THE PAIN STOPPED. NO EFFUSION WAS DETECTED. THE LEAD WAS REPOSITIONED.
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 | 7122Q/58 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |