FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION LEAD
MDR report key: 1073163
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02520
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 13, 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
- CA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
NO MEDWATCH FORM WAS RECEIVED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE EGMS REVEALED NOISE ON THE LEAD AND THE PATIENT RECEIVED SEVERAL SHOCKS. THE LEAD REMAINS IMPLANTED. IT WAS LATER REPORTED THAT THE PHYSICIAN PROGRAMMED TACHY THERAPY OFF. NO OTHER INFORMATION FOR THE PATIENT WAS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ST ACTIVE FIXATION LEAD | DEFIBRILLATION LEAD | LWS | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7001/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |