BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROTECTA XT

    MDR report key: 7416053 · Received April 10, 2018

    Report

    Report Number
    2182208-2018-00499
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    January 1, 2017
    Report Date
    April 10, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. 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: ¿SUCCESSFUL TREATMENT OF VENTRICULAR FIBRILLATION STORM TRIGGERED BY SHORT LONG-SHORT SEQUENCE; TIME TO AVOID MANAGED VENTRICULAR PACING.¿ JOURNAL OF ELECTROCARDIOLOGY 50 (2017) 941 ¿ 943. HTTP://DX.DOI.ORG/10.1016/J.JELECTROCARD.2017.06.005. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. THE ARTICLE INDICATED THE PATIENT RECEIVED SHOCKS DESPITE ¿ANTI-ARRHYTHMIC THERAPY¿ [MEDICATION]. THE AUTHOR CLAIMS THAT THE DEVICE¿S ALGORITHM DID NOT STOP THE SHOCKS FROM HAPPENING. THE DEVICE WAS REPROGRAMMED, AND THE SHOCKS STOPPED, AND THE ARRHYTHMIA WAS SUPPRESSED. THE DEVICE APPEARS TO BE STILL IN USE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262416 PROTECTA XT PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-ICD

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Life Threatening| R