BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTROPHYSIOLOGY CABLE -1804-S

    MDR report key: 1993061 · Received February 10, 2011

    Report

    Report Number
    MW5019405
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    February 7, 2011
    Report Date
    February 10, 2011
    Manufacturer
    IRVINE BIOMEDICAL, INC- A ST. JUDE MEDICAL COMPANY
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS SEDATED AND CANNULATED FOR PROCEDURE WHEN THE CORD TO THE ABLATION GROUND CABLE MALFUNCTIONED. NOTED FRAYED CORD. PROCEDURE WAS CANCELLED. REP MAY HAVE DISCARDED THE DEFECTIVE CORD. NEW CORD WAS AVAILABLE THE NEXT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ELECTROPHYSIOLOGY CABLE -1804-S ELECTROPHYSIOLOGY CABLE DRF IRVINE BIOMEDICAL, INC- A ST. JUDE MEDICAL COMPANY 3244395

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Disability