FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1223478
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03628
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- September 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP95022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
AT IMPLANT, IT WAS REPORTED THAT A LEAD PERFORATION HAD OCCURRED DURING PLACEMENT AND THE PATIENT DEVELOPED PERICARDIAL EFFUSION. THE PATIENT WAS HYPOTENSIVE AND REQUIRED AN INCREASE IN BLOOD VOLUME AND VASOCONSTRICTIVE MEDICATIONS FOR STABILIZATION. THE LEAD REMAINS ACTIVE.
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 | 7120/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |