BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 5331934 · Received December 29, 2015

    Report

    Report Number
    3007566237-2015-04096
    Event Type
    Malfunction
    Date Received
    December 29, 2015
    Report Date
    December 7, 2015
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE DESKTOP CHARGER FOUND A BROKEN CONNECTOR.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT A PATIENT WHOSE INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS HAD THE METAL PART ON THE CON NECTOR PIN BREAK OFF IN (B)(6) 2015, THERE WAS A BENT/BROKEN/LOOSE CONNECTOR PIN ON THE DESKTOP CHARGER. THE PATIENT LIKED TO PLAY WITH THE CORDS. THE PATIENT'S IMPLANT/THERAPY WAS COMPLETELY TURNED OFF AS OF (B)(6) 2015 BECAUSE THEY COULD NOT CHARGE AND SYMPTOMS WERE RETURNING. NO PATIENT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857051 RESTORE STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37761

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR