FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION LEAD
MDR report key: 1073570
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02454
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 12, 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
- NY
- 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 NOISE WAS SENSED ON THE VENTRICULAR CHANNEL. IT HAS NOT BEEN DETERMINED WHETHER THE NOISE IS COMING FROM THE SJM LEAD OR THE MEDTRONIC LEAD. THE PATIENT IS BEING MONITORED.
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 | 1582/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |