FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2243012
·
Received September 11, 2011
Report
- Report Number
- 2017865-2011-06139
- Event Type
- Malfunction
- Date Received
- September 11, 2011
- Date of Event
- July 13, 2011
- 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 Location
- LA
- 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 PRESENTED IN HOSPITAL FOR A VENTRICULAR NIPS PROCEDURE. WHEN DEVICE WAS INTERROGATED, A MESSAGE WAS DISPLAYED FOR POSSIBLE HV LEAD ISSUE. ALERTS HAVE ALSO BEEN RECEIVED FOR OUT OF RANGE IMPEDANCE. ABORTED THERAPIES WERE FOUND. NOISE WAS FOUND WITH PROVOCATION TESTING. INSULATION DAMAGE SUSPECTED. DEVICE WAS REPROGRAMED RV-CAN.
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 | 68 YR |