BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3951123 · Received July 22, 2014

    Report

    Report Number
    3007566237-2014-02036
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 28, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3389-40, LOT# J0337635V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 748251, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE EXTENSION; PRODUCT ID 3389-40, LOT# J0337612V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAD FALLEN 4 DAYS PRIOR TO REPORT AND SINCE THEN THEIR TREMORS HAD RETURNED. WHEN THE PATIENT FELL THEY DID NOT HIT THEIR HEAD. THE PATIENT FELL ON THE SIDE WHERE THE DEVICE WAS OFF. THEY HAD USED THE PATIENT PROGRAMMER TO CHECK THE STATUS AND THE PROGRAMMER STATED THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS ¿ON AND OKAY.¿ THEY HAD SEEN THEIR PRIMARY DOCTOR BUT THE DEVICE WAS NOT CHECKED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428363 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR