FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3090269
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01083
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 8, 2013
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 NOISE WAS OBSERVED ON BOTH THE ATRIAL AND RV (SVC TO RV COIL) LEADS. HIGH VOLTAGE LEAD IMPEDANCE ALSO MEASURED OUT OF RANGE IN THE LAST FEW MONTHS BUT WAS NOTED THAT THIS WAS DUE TO SETTINGS PROGRAMMED TOO CONSERVATIVELY. SYSTEM REMAINS IMPLANTED, AS FURTHER INFORMATION COULD NOT BE OBTAINED AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191440 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | (B)(4) |