FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073107
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02349
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- April 8, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- LWS
- PMA / PMN Number
- PMA00001
- Removal / Correction Number
- NA
- Report Source
- Manufacturer report
- Reporter Location
- NC
- 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 AN ABORTED VF EPISODE WAS OBSERVED DUE TO NOISE ON THE LEAD. THE NOISE WAS REPRODUCIBLE WITH ARM MOVEMENTS. THE PATIENT WILL BE MONITORED. THE DEVICE IS NEAR ERI AND THE LEAD WILL BE REPLACED AT THAT TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1581/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |