BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTIFY DR, DF4 CONNECTOR

    MDR report key: 3791056 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10343
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    March 26, 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
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THE REPORTED RF TELEMETRY ANOMALY WAS NOT CONFIRMED IN THE LABORATORY. THE DEVICE WAS TESTED ON THE BENCH AS WELL AS USING AUTOMATED TEST EQUIPMENT, AND NO ANOMALY WAS FOUND. THE CAUSE OF THE RF TELEMETRY ANOMALY COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING ROUTINE CLINIC EVALUATION OF THE DEVICE, INTERROGATION WAS INTERMITTENT USING THE RADIO FREQUENCY TELEMETRY. INDUCTION TELEMETRY WAS THEN USED AND INTERROGATION WAS NORMAL. PATIENT CONDITION WAS GOOD.

    Description of Event or Problem · 1

    NEW INFORMATION RECEIVED THAT THE DEVICE WAS EXPLANTED DUE TO AN UPGRADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268660 FORTIFY DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2231-40Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR