BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO

    MDR report key: 3991114 · Received August 8, 2014

    Report

    Report Number
    2182208-2014-02186
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    April 1, 2014
    Report Date
    May 2, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P010031
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. CORRESPONDENCE WAS SENT TO THE AUTHOR REQUESTING ADDITIONAL INFORMATION, WITH NO REPLY AT THE TIME OF THIS REPORT. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: SHOCK-INDUCED VENTRICULAR TACHYCARDIA: WHAT IS THE MECHANISM? PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2014;37(4):516-519. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT HAD PRESENTED TO THE CLINIC DUE TO RECEIVING TWO ICD SHOCKS. THE PATIENT¿S DEVICE WAS INTERROGATED AND IT WAS DISCOVERED THAT T-WAVE OVERSENSING WAS THE CAUSE OF THE FIRST VENTRICULAR FIBRILLATION (VF) DETECTION AND ICD SHOCK. THE DEVICE THEN FAILED TO TERMINATE THE RHYTHM. THE SECOND SHOCK FROM THE ICD WAS ABLE TO TERMINATE THE RHYTHM. IT WAS ALSO NOTED THAT THE ICD WAS EXPLANTED AND REPLACED DUE TO IT REACHING ELECTIVE REPLACEMENT INDICATOR (ERI). THE NEW ICD WAS IMPLANTED AND TESTED TO HAVE ADEQUATE SENSING PROGRAMMABILITY. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468706 MAXIMO PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Hospitalization| L| R