BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 5563651 · Received April 8, 2016

    Report

    Report Number
    3004209178-2016-07091
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    March 1, 2016
    Report Date
    April 8, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3389S-40, LOT# V398923, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3389S-40, LOT# V320477, IMPLANTED: (B)(6) 2010, 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 WHOSE INDICATION FOR USE IS PARKINSON'S DUAL AND MOVEMENT DISORDERS REPORTED THE PATIENT WAS FEELING AN ELECTRICAL SHOCK WAVE GOING THROUGH THEIR BODY ON (B)(6) 2016. IT WAS INQUIRED IF THE WIRE COULD BE DAMAGED AND CAUSING THE ELECTRICAL SHOCK. THE PATIENT HAD BEEN GETTING MASSAGES LYING. THE PATIENT HAD BEEN HAVING MUSCLE SPASMS FOR THE PAST TWO WEEKS PRIOR TO (B)(6) 2016. WHEN THE PATIENT PRESSED ON THE IMPLANTABLE NEUROSTIMULATOR (INS) THEY COULD FEEL A LITTLE SHOCK WAVE WHICH HAD OCCURRED ON (B)(6) 2016. THERAPY WAS CHECKED WITH THE PATIENT PROGRAMMER AND WAS ON. THE PATIENT HAD CONTACTED THEIR HEALTHCARE PROFESSIONAL. INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL THAT INDICATED THE PATIENT HAD HAD MUSCLE SPASMS SINCE BEFORE 2013, MOST WERE BETTER. BICEP AND AXILLA, SPASMS HAPPEN OFF/ON ALL DAY AND FELT DID NOT CORRELATE WITH MEDS. SHOCKING WAS NOT REPRODUCIBLE WITH PRESSURE ON GENERATOR AS REPORTED. ALL IMPEDANCE WERE WITHIN NORMAL LIMITS. LEFT GENERATOR WAS ADJUSTED. THE PATIENT QUIT BACLOFEN. THE HEALTHCARE PROFESSIONAL THINKS THE PATIENT IS HALLUCINATING/MISINTERPRETING EVENTS, "FEELS ELECTRONS MOVING OVER HER BODY." COMPLAINED OF INTERMITTENT ELECTRICAL PULSES IN HANDS AND REPORTS HALLUCINATIONS, SEROQUEL STARTED. THE SHOCKING AND MUSCLE SPA SMS HAD RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217574 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Other