BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1111649 · Received August 13, 2008

    Report

    Report Number
    3004209178-2008-04923
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    July 1, 2008
    Report Date
    July 17, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PT BUMPED THE AREA WHERE HIS STIMULATOR WAS IMPLANTED. SINCE THAT TIME, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PT WAS AT HOME. HIS STATUS WAS UNDETERMINED AT THE TIME OF THIS REPORT. THE PT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention EXPLANTED:| LEAD: MODEL 3387| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482| EXTENSION: MODEL 7482| LEAD: MODEL 3387| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7436| IMPLANTED: