FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223606
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03595
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 7, 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
- FL
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT NOISE WAS OBSERVED ON THE LEAD. ALL SHOCKS WERE ABORTED BEFORE THE PATIENT RECEIVED THERAPY. THE NOISE WAS NOT REPRODUCED IN THE CLINIC. THE PATIENT DID NOT REMEMBER WHAT SHE WAS DOING DURING THE TIME OF THE STORED EPISODES. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |