BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADAPTA DR

    MDR report key: 1791059 · Received August 10, 2010

    Report

    Report Number
    2647346-2010-00356
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    April 4, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    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

    THE PATIENT REPORTED THAT HE WAS BIKING UPHILL AND FELT HIS HEART WAS NOT BEATING ENOUGH TO GET UP THE HILL. HE STATED HIS DEVICE WAS PROGRAMMED FROM 60-130, BUT HIS HEART RATE WAS ONLY IN THE 90S AND LOW 100S. FOLLOW-UP INFORMATION RECEIVED REPORTED THERE WERE NO ISSUES WITH THE DEVICE. THE DEVICE WAS REPROGRAMMED ON (B)(6)-2010, BY INCREASING THE UPPER RATE TO 150, CHANGING THE ADL RATE FROM 95 TO 105, AND CHANGING THE EXERTION RESPONSE FROM 3 TO 4. THE PATIENT CAME INTO THE CLINIC AGAIN ON (B)(6)-2010. HE IS DOING FINE AND IS NOW ABLE TO RUN AND BIKE, WITH NO ISSUES. DEVICE IS STILL IN USE. THERE WERE NO PATIENT COMPLICATIONS 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. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention 4076-58 IMPLANTABLE PACING LEAD| 4076-52 IMPLANTABLE PACING LEAD