BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA DR

    MDR report key: 1990256 · Received February 15, 2011

    Report

    Report Number
    6000144-2011-00675
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    November 21, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF MULTIPLE INSTANCES OF A FAST HEART BEAT. THE PATIENT WAS REFERRED TO THE PHYSICIAN FOR FURTHER DISCUSSION. THE DEVICE IS STILL IN USE. NO FURTHER 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. ADDR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other (B)(4) IMPLANTABLE PACING LEAD