FDA Adverse Event
Malfunction
Summary report: N
RIATA PASSIVE FIXATION
MDR report key: 3220292
·
Received July 11, 2013
Report
- Report Number
- 2938836-2013-04138
- Event Type
- Malfunction
- Date Received
- July 11, 2013
- Date of Event
- May 22, 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
- PA
- 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
NEW INFORMATION NOTES DURING A DEVICE CHANGE OUT FOR ERI, THE VENTRICULAR LEAD WAS DISCOVERED TO BE DISLODGED. THE LEAD WAS EXPLANTED ON (B)(6) 2014.
Description of Event or Problem · 1
IT WAS REPORTED THAT MULTIPLE EPISODES OF NONSUSTAINED LEAD NOISE WERE OBSERVED. THE NOISE WAS NOT REPRODUCIBLE IN CLINIC. THE LEAD WILL BE MONITORED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320250 | RIATA PASSIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1570/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR |