BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 8266495 · Received January 22, 2019

    Report

    Report Number
    3004209178-2019-01391
    Event Type
    Malfunction
    Date Received
    January 22, 2019
    Date of Event
    January 6, 2019
    Report Date
    January 22, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761088
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708660, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3708660, SERIAL/LOT #: (B)(4), UBD: 22-JUL-2017, UDI#: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURE REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE PATIENT STARTED TO FEEL INTERMITTENT ZAPS ON THE SIDE OF HIS HEAD NEAR THE EXTENSION. NO KNOWN FACTORS WERE THOUGHT TO HAVE LED OR CONTRIBUTED TO THE ISSUE. THE PATIENT HAD BEEN BED RIDDEN FOR SOME TIME BECAUSE OF PNEUMONIA BUT DENIED ANY FALLS OR IMPACT TO HIS DEEP BRAIN STIMULATION (DBS) SYSTEM. THE PATIENT CONTINUED TO RECEIVE VERY GOOD THERAPY CONTROL WITH HIS SYSTEM. IT WAS REPORTED THE PATIENT ALWAYS TURNED THE DEVICE OFF AT NIGHT TO PRESERVE BATTERY LIFE. THE PATIENT STATED HE SEEMED TO STILL FEEL A SENSATION ON THE SIDE OF HIS HEAD DESPITE BEING TURNED OFF BUT NOT AS STRONG AS WHEN IT WAS ON. THE PATIENT DECIDED TO SHUT OF HIS DEVICE FOR A FEW DAYS BUT STILL SEEMED TO FEEL A SLIGHT SENSATION INTERMITTENTLY. THE IMPEDANCES WERE CHECKED AND WITHIN NORMAL LIMITS. THE LEAD EXTENSION CONNECTION WAS ALSO PALPATED AND MANIPULATED WHILE RUNNING ANOTHER IMPEDANCE TEST AND RESULTS WERE WITHIN NORMAL LIMITS. THE PATIENT WAS INSTRUCTED TO CONTINUE TO USE HIS DBS IN THE NORMAL FASHION AND REPORT BACK IF IT CONTINUED. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO SURGICAL INTERVENTION OCCURRED OR WAS PLANNED. THE PATIENT HAD A MEDICAL HISTORY OF ESSENTIAL TREMOR AND PNEUMONIA. THE PATIENT WAS ALIVE WITHOUT INJURY AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59401 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761088

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR