BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MAXIMO DR

    MDR report key: 4159848 · Received October 10, 2014

    Report

    Report Number
    2182208-2014-02887
    Event Type
    Injury
    Date Received
    October 10, 2014
    Date of Event
    January 1, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 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. 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: INAPPROPRIATE DETECTION OF A SUPRAVENTRICULAR TACHYCARDIA AS DUAL TACHYCARDIA BY THE PR LOGIC® ALGORITHM. INDIAN PACING AND ELECTROPHYSIOLOGY JOURNAL. 2014;14(3):161-164. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). THE PATIENT RECEIVED AN INAPPROPRIATE SHOCK DUE TO THE DEVICE INCORRECTLY CLASSIFYING THE PATIENT¿S RHYTHM. THE PATIENT UNDERWENT AN ELECTROPHYSIOLOGY STUDY WITH ABLATION. THE ICD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    638320 MAXIMO DR DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MEDTRONIC, INC. 7278

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| L| R