BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA D

    MDR report key: 7594904 · Received June 12, 2018

    Report

    Report Number
    2182208-2018-01102
    Event Type
    Malfunction
    Date Received
    June 12, 2018
    Date of Event
    April 18, 2017
    Report Date
    June 12, 2018
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT.SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: A DEVICES¿ GAME OF THRONES: CARDIAC RESYNCHRONIZATION THERAPY VS. PACEMAKER. EUROPACE. 2017; 19(12):2042-2046. DOI: 10.1093/EUROPACE/EUX081. 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 A PATIENT WITH A COMPETITOR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR EXPERIENCING OUTPUT INHIBITION DUE TO DEVICE INTERACTION WITH AN IMPLANTABLE PULSE GENERATOR (IPG). THE ARTICLE REPORTS THE IPG CREATED ELECTROMAGNETIC INTERFERENCE DUE TO THE AUTOMATIC REVERSION OF OVO MODE TO BACKUP VVI AS THE DEVICE REACHED ELECTIVE REPLACEMENT INDICATOR (ERI). THE IPG WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434835 ADAPTA D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. ADD01

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR