FDA Adverse Event
Injury
Summary report: N
RIATA ACTIVE FIXATION
MDR report key: 1895566
·
Received November 10, 2010
Report
- Report Number
- 2017865-2010-04287
- Event Type
- Injury
- Date Received
- November 10, 2010
- Date of Event
- September 8, 2010
- Manufacturer
- ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI
- 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 A VENTRICULAR LOSS OF CAPTURE WAS OBSERVED ON THE HOLTER MONITOR. REPROGRAMMING OF THE DEVICE WAS ATTEMPTED BUT UNSUCCESSFUL. REVIEW OF LATEST HOLTER MONITOR RECORDINGS SHOWED SPIKES IN PACING IMPEDANCES. THE PHYSICIAN HAS DECIDED TO PARTIALLY CAP THE PACE/SENSE PORTION OF THE RV LEAD AND REPALCE WITH OLD PACE/SENSE LEAD. THE RV LEAD DEFIB PORTION WILL REMAIN ACTIVE.
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 | 73 YR | Required Intervention |