FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1223687
·
Received November 10, 2008
Report
- Report Number
- 2017865-2008-03571
- Event Type
- Injury
- Date Received
- November 10, 2008
- Date of Event
- August 5, 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
NA
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING FOLLOW-UP AN ERROR MESSAGE WAS DISPLAYED STATING CHARGES COULD NOT BE SUCCESSFUL DUE TO RESIDUAL CURRENT PROTECTION. DURING DEVICE EXPLANT, LEAD INSULATION DAMAGE WAS NOTED. THE LEAD WAS DESTROYED DURING EXPLANT, AND WILL NOT BE RETURNED.
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 | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |