FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3090272
·
Received May 2, 2013
Report
- Report Number
- 2938836-2013-01088
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- February 7, 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 Location
- WA
- 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 DURING DEVICE CHANGE OUT DUE TO NORMAL ERI. THE RV LEAD WAS TESTED AND NO ANOMALIES WERE NOTED. THE PATIENT WAS ASYMPTOMATIC. THE PHYSICIAN PERFORMED DFTS WITHOUT PERFORMING HV LEAD IMPEDANCE TESTS. DURING DFT TESTING, THE HV THERAPY WAS UNSUCCESSFUL DUE TO LOW LEAD IMPEDANCE WHICH SHORTED OUT THE COMPETITORS ICD. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191453 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |