FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1830451
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03464
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- July 24, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM
- 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
PATIENT PRESENTED TO THE HOSPITAL AFTER RECEIVING PATIENT NOTIFIER ALERT AND COMPLAINTS OF DIAPHRAGMATIC STIMULATION. UPON INTERROGATION, AN ALERT WAS PRESENT FOR HV LEAD IMPEDANCE OUT OF RANGE. A LOSS OF CAPTURE AND DECREASE IN R-WAVES WERE ALSO NOTED. X-RAY REVEALED THAT THE LEAD HAD BEEN PULLED UP INTO THE SVC. THE LEAD WAS REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DURATA STS OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7121/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention |