FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242847
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06148
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 14, 2011
- 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
- MS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT T-WAVE OVERSENSING WAS OBSERVED. THE PATIENT RECEIVED INAPPROPRIATE THERAPY DUE TO NOISE. EMI AT THE TIME OF THE EPISODES WAS SUSPECTED. NOISE WAS NOT REPRODUCIBLE WITH ISOMETRICS. THE PHYSICIAN OPTED TO REVERSE THE RV PACE/SENSE AND LV LEADS IN THE DEVICE HEADER DUE TO THE PATIENT'S CONDITION. THE LEAD REMAINS IMPLANTED.
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 | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | 1888TC/58 (B)(4) |