BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 4113448 · Received September 24, 2014

    Report

    Report Number
    3004209178-2014-17615
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    PMA / PMN Number
    P980035
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    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

    IT WAS REPORTED THAT DURING ROUTINE DEVICE INTERROGATION, THE ATRIAL HIGH RATE AND VENTRICULAR HIGH RATE EPISODES WERE ATTEMPTED TO BE OPENED BUT NO DATA WAS AVAILABLE AND A MESSAGE INDICATED ¿INVALID DATA¿. IT WAS FURTHER REPORTED THAT THERE WAS A POSSIBLE POWERON RESET (POR). THE DEVICE REMAINS IN USE. ADDITIONAL INFORMATION NOTED THAT THE PATIENT HAD NOT HAD PROCEDURES OR SURGERIES SINCE LAST SESSION AND THERE WAS NO KNOWN EXPOSURE TO ELECTROMAGNETIC INTERFERENCE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    596017 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRS1

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 MO 4968-25 LEAD, 4968-25 LEAD