BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAPTA SR

    MDR report key: 2053236 · Received April 13, 2011

    Report

    Report Number
    6000144-2011-01600
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    NVZ
    PMA / PMN Number
    P980035/S043
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, 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 DEVICE SWITCHED TO UNIPOLAR. IT WAS ALSO REPORTED THAT THE LEAD HAD AN APPARENT FRACTURE AND THE PATIENT WAS NOT SATISFIED WITH THE QUALITY OF THE PRODUCTS. THE DEVICE AND LEAD ARE STILL 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 SR IMPLANTABLE PULSE GENERATOR NVZ MEDTRONIC MED REL, INC. ADSR01 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other