BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA

    MDR report key: 2964653 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02273
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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. (B)(4).

    Description of Event or Problem · 1

    FOLLOW-UP WAS CONDUCTED AND FROM THE INFORMATION OBTAINED IT WAS REPORTED THAT THE PROBLEM ENDED UP BEING NOTHING DEVICE RELATED BUT A MISINTERPRETATION OF THE ECG (ELECTROCARDIOGRAM) BY THE HOSPITAL AND OUR TECHNICAL SERVICES. THIS MISINTERPRETATION WAS CAUSED DUE TO THE VEGM NOT BEING PROGRAMMED TO RECORD A RHYTHM AT THE TIME OF SAVING AN ECG WHICH APPEARED TO BE A PAUSE IN THE PATIENT'S HEART RATE. THEREFORE, NO X-RAY WAS DONE AND THERE WAS NO REPROGRAMMING. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER SYNCOPE. THE DEVICE WAS TESTED AND FOUND THAT THERE WAS A PAUSE ON VEGM (VENTRICULAR ELECTROGRAM). IT WAS NOTED THAT THE VEGM OCCURRED DURING TELEMETRY AND WAS NOT RELATED TO SYNCOPE. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66289 ADAPTA PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 00076 YR 5076 X2 IMPLANTABLE PACING LEADS