FDA Adverse Event
Injury
Summary report: N
RIATA ST OPTIM ACTIVE FIXATION
MDR report key: 1073147
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02504
- Event Type
- Injury
- Date Received
- July 11, 2008
- Date of Event
- May 30, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- 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 CLINIC WITH COMPLAINTS OF INTERMITTENT PAIN NEAR THEIR LEFT NIPPLE. MICRO-DISLODGEMENT WAS SUSPECTED, SINCE X-RAY SHOWS THAT THE LEAD APPEARED TO BE IN THE SAME POSITION. AN INCREASED IN THRESHOLD, DECREASED IN SENSING, AND A DROP IN IMPEDANCE WERE OBSERVED. AS SUCH, THE LEAD WAS REPOSITIONED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST OPTIM ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7020/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |