FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223686
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03570
- Event Type
- Injury
- Date Received
- November 10, 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 Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
ANALYSIS OF THE STORED EGMS SHOWED THAT THE PATIENT RECEIVED INAPPROPRIATE THERAPY, DUE TO NOISE. FLUOROSCOPY REVEALED LEAD DISINTEGATION AT THE LEVEL OF THE TRICUSPID VALVE. HENCE, THE LEAD WAS REPLACED.
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 | 1580 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |