FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION
MDR report key: 1050925
·
Received May 27, 2008
Report
- Report Number
- 2017865-2008-01864
- Event Type
- Injury
- Date Received
- May 27, 2008
- Date of Event
- March 28, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- 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
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
PATIENT PRESENTED TO THE HOSPITAL AFTER EXPERIENCING PAIN IN THE THORAX. LOSS OF CAPTURE AND NO SENSING WERE OBSERVED. A DECREASE IN IMPEDANCE WAS ALSO NOTED. AN X-THORAX WAS PERFORMED AND PERFORATION/DISLODGEMENT WAS SUPSECTED. LEAD WAS REPOSITIONED. THE PATIENT HAD A HISTORY OF MYOCARDIAL INFARCTION. THERE WERE NO CONSEQUENCES TO THE PATIENT.
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 | 7122/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |