FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1830498
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03448
- Event Type
- Injury
- Date Received
- September 10, 2010
- Date of Event
- June 15, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- 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 A POCKET REVISION WAS PERFORMED WHEN THE PATIENT COMPLAINED OF PAIN. WHEN THE POCKET WAS OPENED, THE SUTURE SLEEVE COULD NOT BE FOUND. FLUOROSCOPY REVEALED THAT IT WAS FREE-FLOATING IN THE ATRIUM. WHILE SEEING THIS ON FLOUROSCOPY, THE SUTURE SLEEVE EMBEDDED ITSELF INTO A PULMONARY ARTERY. THE PHYSICIANS DID NOT BELIEVE THE SUTURE SLEEVE WOULD MOVE FROM THAT LOCATION, SO THEY LEFT IT AS IS. THE LEAD WAS EXPLANTED AND REPLACED.
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 | 78 YR | Required Intervention |