BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KINETRA

    MDR report key: 1181760 · Received September 30, 2008

    Report

    Report Number
    2182207-2008-06219
    Event Type
    Malfunction
    Date Received
    September 30, 2008
    Date of Event
    September 4, 2008
    Report Date
    September 4, 2008
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    THE PATIENT BUMPED HIS HEAD ON THE REFRIGERATOR. HE STATED THERE DID NOT APPEAR TO BE ANY SWELLING AND THE STIMULATION SEEMED TO BE WORKING PROPERLY. SEVEN DAYS LATER THE PATIENT REPORTED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT WAS AT HOME. HIS STATUS WAS "GOOD". THE PATIENT WAS ENCOURAGED TO CONTACT HIS HEALTH CARE PROFESSIONAL. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KINETRA MHY MEDTRONIC NEUROMODULATION 7428 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LEAD: MODEL 3389S| EXTENSION: MODEL 7482A| PROGRAMMER: MODEL 7436| EXTENSION: MODEL 7482A| EXPLANTED:| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3389S| EXPLANTED: