FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 3220259
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04161
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 29, 2013
- 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
- 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 ASYMPTOMATIC PATIENT PRESENTED TO CLINIC FOR NORMAL FOLLOW UP. REVIEW OF THE EGMS SHOWED CROSSTALK. LEAD DISLODGEMENT WAS SUSPECTED. PATIENT TO BE SENT FOR IMAGING AND POSSIBLE LEAD REPLACEMENT. .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321102 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR |