BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 5858411 · Received August 9, 2016

    Report

    Report Number
    3004209178-2016-15802
    Event Type
    Malfunction
    Date Received
    August 9, 2016
    Date of Event
    January 6, 2012
    Report Date
    August 9, 2016
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    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

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389S-40, LOT# V012196, PRODUCT TYPE: LEAD; PRODUCT ID 3389S-40, LOT# V067514, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A CONSUMER REPORTED THAT THEIR DEEP BRAIN STIMULATION (DBS) WAS IMPLANTED TO HELP WITH THE PATIENT'S UPPER LIMB SPASTICITY AND THE RIGHT SIDE WORKED, BUT THE LEFT SIDE WAS NOT WORKING SINCE IMPLANT. THE PATIENT THOUGHT THE LEAD MAY HAVE BEEN PUT IN WRONG. THE PATIENT'S SPASTICITY HAD WORSENED OVER THE YEARS SINCE IMPLANT AND THEY HAD A HARDER TIME WALKING AND THEY WERE MORE SPASTIC LIKE THE LAST COUPLE OF YEARS. THE PATIENT DID NOT KNOW IF THE SYMPTOMS WERE FROM A PRE-EXISTING BACK PAIN AND THEY THROUGH IT MAY BE COMING FROM THEIR PRE-EXISTING NEUROLOGICAL CONDITION. DOCTORS HAD NOT BEEN ABLE TO DIAGNOSE THE PATIENT'S PRE-EXISTING CONDITION AS PARKINSON'S DISEASE OR ESSENTIAL TREMOR. THE PATIENT THOUGHT THE PRE-EXISTING CONDITION WAS FROM BIRTH WHEN THEY WERE NOT BREATHING RIGHT AWAY. THE PATIENT'S RIGHT ARM HAD BIGGER MOVEMENTS AND THEIR LEFT HARM HAD CONSTANT SMALL TREMORS. THE PATIENT STATED THE "CORDS" IN THEIR ARM AND LEGS WERE REAL TIGHT. IN THE PAST, THE PATIENT HAD NUMEROUS CT MYELOGRAMS, BUT NONE OF THEM HAD BEEN PRESCRIBED DUE TO AN ISSUE WITH THE PATIENT'S THERAPY. ON (B)(6) 2016, THE PATIENT HAD AN APPOINTMENT WITH AN HCP FOR A TRIAL PAIN STIMULATOR. THE PATIENT'S INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511877 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR