BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 7664020 · Received July 5, 2018

    Report

    Report Number
    3007566237-2018-01988
    Event Type
    Injury
    Date Received
    July 5, 2018
    Date of Event
    January 11, 2018
    Report Date
    July 5, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: RUEDA, V.P., CACERES JEREZ, L.E., GOMEZESE, O.F.O., VILLALOBOS, M.P.G. CASES SERIE: REFRACTORY ANGINA MANAGEMENT WITH SPINAL CORD STIMULATOR. EXPERIENCE AT HOSPITAL INTERNACIONAL DE COLOMBIA. NEUROMODULATION 2018; 21: E20. DOI: 10.1111/NER.12774. PLEASE NOTE THE EVENT DATE IS BASED OFF OF WHEN THE ABSTRACT WAS PRESENTED AT THE ANNUAL MEETING OF THE NORTH AMERICAN NEUROMODULATION SOCIETY AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: THE REFRACTORY ANGINA IS DEFINED AS A CHRONIC PATHOLOGY CHARACTERIZED BY THE PERMANENT PAIN OR CHEST DISCOMFORT FOR LONGER THAN THREE MONTHS. THE USE OF THE SPINAL NEUROMODULATION IS ONE OF THE LAST THERAPEUTIC OPTIONS, THE OBJECTIVE TO COMPARE THE EVOLUTION OF THE NYHA FUNCTIONAL CLASS AND THE AUTONOMY IN DAILY LIFE ACTIVITIES THROUGH THE BARTHEL SCALE IN PATIENTS WITH REFRACTORY HEART FAILURE TREATED WITH AN SPINAL NEUROMODULATOR FROM 2007 TO 2017 AT THE HOSPITAL INTERNATIONAL DE COLOMBIA (HIC). AFTER REVIEWING THE MEDICAL RECORDS AND APPLYING THE SCALES, A SIGNIFICANT IMPROVEMENT WAS FOUND IN THE FUNCTIONAL CLASS ALONG WITH PATIENT INDEPENDENCE AFTER THE IMPLANTATION OF THE SPINAL NEUROMODULATOR (SN). REPORTED EVENT: IT WAS REPORTED THE PATIENT¿S DEVICE SHUT DOWN AFTER THE PATIENT WAS STRUCK BY LIGHTNING. IT WAS FURTHER REPORTED THAT THIS LEAD TO ¿HEART FAILURE WHICH WAS CONTROLLED BY REPROGRAMMING A NEW SN.¿ THE AUTHORS NOTED THE EVENT WAS AN ¿UNUSUAL COMPLICATION.¿ NO FURTHER EVENT INFORMATION WAS REPORTED; NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506461 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention