BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7550370 · Received May 29, 2018

    Report

    Report Number
    3007566237-2018-01604
    Event Type
    Malfunction
    Date Received
    May 29, 2018
    Date of Event
    December 11, 2017
    Report Date
    July 6, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL REVIEW INDICATES THIS INFORMATION WAS ALREADY REPORTED IN MANUFACTURER¿S REPORT #3007566237-2017-00722. ANY ADDITIONAL INFORMATION REGARDING THE EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THAT REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PREZELJ, N., TROST, M., GEORGIEV, D., FLISAR, D. LIGHTNING MAY POSE A DANGER TO PATIENTS RECEIVING DEEP BRAIN STIMULATION: CASE REPORT. J NEUROSCI. 2018. DOI: 10.3171/2017.12.JNS172258. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT WAS NOT YET AVAILABLE ONLINE WHEN THE MANUFACTURER BECAME AWARE OF THE EVENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. [PREZELJ_LIT.PDF].

    Description of Event or Problem · 1

    SUMMARY: DEEP BRAIN STIMULATION (DBS) IS AN ESTABLISHED TREATMENT OPTION FOR ADVANCED STAGES OF PARKINSON¿S DISEASE AND OTHER MOVEMENT DISORDERS. IT IS KNOWN THAT DBS IS SUSCEPTIBLE TO STRONG ELECTROMAGNETIC FIELDS (EMFS) THAT CAN BE GENERATED BY VARIOUS ELECTRICAL DEVICES AT WORK, HOME, AND IN MEDICAL ENVIRONMENTS. EMFS CAN INTERFERE WITH THE PROPER FUNCTIONING OF IMPLANTABLE PULSE GENERATORS (IPGS). VERY STRONG EMFS CAN GENERATE INDUCTION CURRENTS IN IMPLANTED ELECTRODES AND EVEN DAMAGE THE BRAIN. MANUFACTURERS OF DBS DEVICES HAVE ISSUED A LIST OF WARNINGS ON HOW TO AVOID THIS DANGER. STRONG EMFS CAN RESULT FROM NATURAL FORCES AS WELL. THE AUTHORS PRESENT THE CASE OF A (B)(6) WOMAN WHO WAS BEING TREATED WITH A RECHARGEABLE DBS SYSTEM FOR NECK DYSTONIA WHEN HER APARTMENT WAS STRUCK BY LIGHTNING. DOMESTIC ELECTRONIC DEVICES THAT WERE OPERATING DURING THE EVENT WERE BURNED AND DESTROYED. THE WOMAN¿S IPG SWITCHED OFF BUT REMAINED UNDAMAGED, AND SHE SUFFERED NO NEUROLOGICAL CONSEQUENCES. REPORTED EVENTS: A (B)(6) WOMAN WITH BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR DYSTONIA EXPERIENCED ¿VERY GOOD¿ CLINICAL RESPONSE; APPROXIMATELY FIVE YEARS AFTER IMPLANT THE ELECTRICAL INSTALLATION OF HER APARTMENT WAS STRUCK BY LIGHTNING DURING A THUNDERSTORM, CAUSING HER IMPLANTABLE NEUROSTIMULATOR (INS) TO SWITCH OFF AND ELECTRICAL DEVICES THAT WERE IN USE AT THE TIME, SUCH AS A TELEVISION AND AIR CONDITIONER, TO BE BURNED AND DESTROYED. NO DBS RECHARGING ACCESSORIES WERE CHARGING DURING THE EVENT, SO THEY WERE UNDAMAGED. THE PATIENT REPORTEDLY NOTICED SOMETHING WAS WRONG ONLY AN HOUR AFTER THE STORM SUBSIDED WHEN DYSTONIC NECK TREMOR REAPPEARED. WHEN SHE CHECKED THE FUNCTION OF HER IPG, THE POWER ON RESET (POR) WARNING APPEARED ON HER PATIENT PROGRAMMER¿S DISPLAY. UPON VISITING THEIR HEALTH CARE PROVIDER (HCP) THE INS WAS CONFIRMED TO BE TURNED OFF, BUT ALL STIMULATION PARAMETERS REMAINED UNCHANGED, THE BATTERY REMAINED 50% CHARGED (AS EXPECTED), AND THE SYSTEM OVERALL WAS FOUND TO BE UNDAMAGED. THE PATIENT¿S DYSTONIC TREMOR RESOLVED ALMOST IMMEDIATELY AFTER TURNING THE STIMULATOR BACK ON AND THE PATIENT SUFFERED NO OTHER NEUROLOGICAL CONSEQUENCES. IT WAS NOT POSSIBLE TO ASCERTAIN ANY ADDITIONAL SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391576 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR