FDA Adverse Event
Malfunction
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1073496
·
Received July 11, 2008
Report
- Report Number
- 2017865-2008-02395
- Event Type
- Malfunction
- Date Received
- July 11, 2008
- Date of Event
- May 16, 2008
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- Z0457
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH
- 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 THE PATIENT HAD A SYNCOPAL EVENT. REVIEW OF THE EGMS REVEALED NON-PHYSIOLOGIC NOISE ON THE LEAD AND INHIBITED PACING.
Description of Event or Problem · 1
NEW INFORMATION NOTES THAT THE LEAD WAS CAPPED IN 2008 DUE TO NOISE. RECENTLY DURING DEVICE CHANGE OUT DUE TO ERI, EXTERNALIZED CONDUCTORS WERE OBSERVED ON THE ACTIVE DEFIB PORTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RIATA ACTIVE FIXATION | DEFIBRILLATION LEAD | NVY | ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION | 1580/65 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR |