FDA Adverse Event
Injury
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 2242994
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06211
- Event Type
- Injury
- Date Received
- September 11, 2011
- Date of Event
- July 22, 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
- GA
- 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 THE PATIENT WAS COMPLAINING OF DIZZY SPELLS AND NEAR SYNCOPAL EPISODES. PATIENT IS PACEMAKER DEPENDENT. NOISE WAS DETECTED ON BOTH THE ATRIAL AND VENTRICULAR CHANNEL. THE NOISE COULD NOT BE REPRODUCED. LEAD DAMAGE UNDER FLUOROSCOPY WAS OBSERVED. THE VENTRICULAR LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | (B)(4) |