BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ELLIPSE DR, DF-4 CONNECTOR

    MDR report key: 4210693 · Received October 29, 2014

    Report

    Report Number
    2938836-2014-17219
    Event Type
    Malfunction
    Date Received
    October 29, 2014
    Date of Event
    September 12, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    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 PATIENT PRESENTED TO THE CLINIC AFTER FEELING SYMPTOMATIC. DEVICE DID NOT RESPOND APPROPRIATELY TO VT. REVIEW OF THE EGMS INDICATED EPISODES OF VT THAT WAS MISDIAGNOSED AS SVT. SUGGESTED PROGRAMMING CHANGES WERE MADE TO DEVICE. PATIENT WAS FINE AFTER EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693693 ELLIPSE DR, DF-4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2311-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR