BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA D

    MDR report key: 4833305 · Received June 10, 2015

    Report

    Report Number
    2182208-2015-02063
    Event Type
    Injury
    Date Received
    June 10, 2015
    Date of Event
    January 1, 2015
    Report Date
    March 4, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    NVZ
    PMA / PMN Number
    1-CARD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE PMA NUMBER FOR THIS REPORT LISTED IS PART OF A COMBINATION OF PMAS CONSIDERED THE "1-CARD" AND CONSISTS OF P820003, P850051, P890003, P930022, P970012 AND P980035. 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: MANAGED VENTRICULAR PACING BELOW THE LOWER RATE LIMIT DURING DDD TO AAI TRANSITION: WHAT IS THE MECHANISM? PACE PACING AND CLINICAL ELECTROPHYSIOLOGY. 2015;38(2):286-288. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS RECEIVED WHICH CONTAINED INFORMATION REGARDING THIS PATIENT¿S PACEMAKER. THE ARTICLE NOTED THAT DURING A ROUTINE 24-HOUR HOLTER RECORDING, THE PACEMAKER PACED LOWER THAN THE PROGRAMMED RATE DURING THE TRANSITION FROM DDD TO AAI (DUAL PACED/DUAL SENSED VS ATRIAL PACED/ATRIAL SENSED). THE PACEMAKER WAS REPROGRAMMED AND APPEARS TO BE STILL IN USE. THE ARTICLE CONCLUDED THIS IS A ¿NORMAL MANAGED VENTRICULAR PACING (MVP) ALGORITHM¿ AND SHOULD NOT BE ¿MISINTERPRETED¿ AS AN ¿ABNORMAL SENSING EVENT OR MALFUNCTION.¿ NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377909 ADAPTA D PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC, INC. ADD01

    Patients

    Seq Age Sex Outcome Treatment
    1 00051 YR Required Intervention