BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 7416811 · Received April 10, 2018

    Report

    Report Number
    3004209178-2018-07375
    Event Type
    Injury
    Date Received
    April 10, 2018
    Date of Event
    February 23, 2018
    Report Date
    April 27, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NVZ
    UDI-DI
    00613994222084
    PMA / PMN Number
    P980035
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS, HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY WAS PERFORMED AND NO ANOMALIES WERE FOUND. MEDTRONIC, INC. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INTERROGATION, IT WAS NOTED THAT THE DEVICE HAD RECORDED MULTIPLE EPISODES OF ATRIAL HIGH RATES, HOWEVER, THE EGM SAID THE DATA WAS INVALID. THE INTERROGATION SESSION WAS ENDED, AND THE DATA WAS CLEARED. A SUBSEQUENT INTERROGATION REVEALED THAT THE EPISODES WERE NOW GONE AND COULD NOT BE RETRIEVED. 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
    258349 ADAPTA DR PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ MEDTRONIC MED REL MEDTRONIC PUERTO RICO ADDRL1 00613994222084

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention