BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 2529975 · Received April 12, 2012

    Report

    Report Number
    6000144-2012-02177
    Event Type
    Injury
    Date Received
    April 12, 2012
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    Z-2120-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REMOTE MONITORING TRANSMISSION FROM THE DEVICE SHOWED VENTRICULAR CAPTURE MANAGEMENT WHERE SEVERAL TIMES THE MEASUREMENTS WERE GREATER THAN 2.5 VOLTS AND SOME WEEKS WITH NO CHECKS. IT WAS NOTED THAT THE THRESHOLDS HAVE BEEN STABLE WHEN CHECKED IN THE OFFICE. THE VENTRICULAR CAPTURE MANAGEMENT FEATURE WAS REPROGRAMMED TO MONITOR SINCE IT WAS NOT MEASURING CORRECTLY AND 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
    1 ADAPTA DR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADDRL1

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 5076 X2 IMPLANTABLE PACING LEADS