FDA Adverse Event
Malfunction
Summary report: N
RIATA ST PASSIVE FIXATION
MDR report key: 1895640
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04447
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- September 7, 2010
- 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
- AL
- 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 SHORTLY AFTER ICD IMPLANT, DURING DFT TESTING, THE PATIENT HAD TO BE EXTERNALLY RESCUED. AN ALERT MESSAGE STATED NO MORE THERAPIES AVAILABLE. THE DEVICE WENT INTO BVVI MODE. AFTER CLEARING THE RESET, THE DEVICE REPORTED LOW IMPEDANCE AND POCKET STIMULATION. THE PHYSICIAN OPTED TO PROGRAM OFF THE SVC COIL AND REPLACE THE ICD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7040/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR |