FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 2242679
·
Received September 10, 2011
Report
- Report Number
- 2017865-2011-06153
- Event Type
- Malfunction
- Date Received
- September 10, 2011
- Date of Event
- June 7, 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
- NY
- 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 RECEIVED A VIBRATORY ALERT FOR HIGH HV IMPEDANCE MEASUREMENTS. TESTING IN THE CLINIC VIA ISOMETRICS, ARM MOVEMENT, AND POCKET MANIPULATION DID NOT REVEAL ANY OUT OF RANGE NUMBERS. THE VALUES WERE ALL WITHIN RANGE. THE HVLI TREND WAS STABLE EXCEPT FOR A FEW OUT-OF-RANGE VALUES. THE PHYSICIAN ELECTED TO MONITOR THE LEAD FOR ANY IMPEDANCE CHANGES.
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 | 67 YR |