BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7150930 · Received December 28, 2017

    Report

    Report Number
    3007566237-2017-05328
    Event Type
    Malfunction
    Date Received
    December 28, 2017
    Date of Event
    January 1, 2017
    Report Date
    June 4, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATES THAT INFORMATION FROM MANUFACTURER¿S REPORT #3007566237-2018-01319 WAS ALREADY REPORTED IN THIS REPORT ( #3007566237-2017-05328). ANY ADDITIONAL INFORMATION REGARDING THAT EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THIS REPORT. CITATION: PREZELJ, N., TROST, M., GEORGIEV, D., FLISAR, D. LIGHTNING MAY POSE A DANGER TO PATIENTS RECEIVING DEEP BRAIN STIMULATION: CASE REPORT. JOURNAL OF NEUROSURGERY. 2018. DOI: 10.3171/2017.12.JNS172258 D2/PMA: DYSTONIA IS NOT AN APPROVED ON-LABEL INDICATION FOR ACTIVA RC (MODEL: 37612). EVENT OCCURRED IN (B)(6). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL REVIEW INDICATES THAT INFORMATION IN THIS REPORT WAS ALREADY REPORTED IN MANUFACTURER'S REPORT #3007566237-2017-00722. ANY ADDITIONAL INFORMATION REGARDING THAT EVENT WILL BE SUBMITTED AS A SUPPLEMENTAL SUBMISSION TO THAT REPORT. 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 PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE HCP REVIEWED A MANUSCRIPT IN THE LAST SEVERAL MONTHS OF A WOMAN WHO WAS RECHARGING DURING AN ELECTRICAL STORM WHEN THEIR APARTMENT GOT STRUCK BY LIGHTNING, RESULTING IN A DEVICE MALFUNCTION. NO PATIENT SYMPTOMS WERE ALLEGED AND NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    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) YEAR-OLD 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 EVENT: ONE (B)(6) YEAR OLD WOMAN WITH BILATERAL GLOBUS PALLIDUS INTERNUS (GPI) DEEP BRAIN STIMULATION (DBS) FOR NECK DYSTONIA EXPERIENCED A LOSS OF STIMULATION WHEN HER HOME WAS STRUCK BY LIGHTNING DURING A THUNDERSTORM. THE PATIENT WAS NOT CHARGING THE IMPLANTABLE NEUROSTIMULATOR (INS) AND THE RECHARGER WAS DISCONNECTED FROM THE POWER SUPPLY AT THE TIME OF THE EVENT; THEREFORE, THE RECHARGER AND INS WERE NOT DESTROYED. ABOUT AN HOUR AFTER THE STORM, THE PATIENT'S DYSTONIC NECK TREMOR REAPPEARED. A POWER ON RESET (POR) MESSAGE WAS DISPLAYED ON THE PROGRAMMER DISPLAY WHEN THE INS STATUS WAS CHECKED. THE PATIENT KNEW SOMETHING WAS WRONG, AND WAS CONCERNED THE DEVICE WAS DAMAGED; HOWEVER, EXAMINATION DETERMINED STIMULATION HAD TURNED OFF AND ALL OTHER PARAMETERS REMAINED UNCHANGED INCLUDING THE CHARGE LEVEL WHICH WAS AT 50%. THE PATIENT SUFFERED NO NEUROLOGICAL CONSEQUENCES. TURNING THE INS ON RESOLVED THE DYSTONIC TREMOR ALMOST IMMEDIATELY AND THE NECK DYSTONIA IMPROVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930548 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR