FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1895580
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04323
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- May 3, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED LATE DUE TO DELAY IN RECEIVING PAPERWORK. THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED UNSTABLE R-WAVES DUE TO T-WAVE OVERSENSING WHICH RESULTED IN INAPPROPRIATE SHOCKS. THE PHYSICIAN FELT THE OVERSENSING WAS PHYSIOLOGICAL. THE LEAD WAS REMOVED AND REPLACED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Required Intervention |