FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1830726
·
Received September 10, 2010
Report
- Report Number
- 2017865-2010-03296
- Event Type
- Malfunction
- Date Received
- September 10, 2010
- Date of Event
- June 25, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMAP950022
- Removal / Correction Number
- NA
- 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 THE LEAD IMPEDANCE HAD INCREASED. ABOUT A WEEK LATER AT A FOLLOW-UP, THE IMPEDANCE WAS IN RANGE. THE VIBRATION FEATURE WAS TURNED BACK ON AND THE PATIENT WAS TOLD TO CALL IF IT VIBRATED AGAIN. THE PHYSICIAN WILL CONTINUE TO MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1582 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |