FDA Adverse Event
Malfunction
Summary report: N
RIATA ST ACTIVE FIXATION
MDR report key: 3210654
·
Received July 8, 2013
Report
- Report Number
- 2938836-2013-03296
- Event Type
- Malfunction
- Date Received
- July 8, 2013
- Date of Event
- May 1, 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
- WA
- 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 THE LEAD WAS REPLACED DURING A DEVICE CHANGE OUT DUE TO NOISE OBSERVED ON STORED ELECTROGRAMS. THE PATIENT DID NOT RECEIVE THERAPY DUE TO NOISE. THE NOISE WAS REPRODUCIBLE THROUGH ARM MOVEMENT TEST. THE ELECTRICAL TESTS OF THE LEAD WERE NORMAL. THE LEAD WAS CAPPED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 309238 | RIATA ST ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 7000/60 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR |