BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9477234 · Received December 16, 2019

    Report

    Report Number
    3007566237-2019-02559
    Event Type
    Malfunction
    Date Received
    December 16, 2019
    Date of Event
    October 1, 2019
    Report Date
    December 16, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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) REGARDING A PATIENT. THE HCP REPORTED THAT THE PATIENT¿S DEVICE WAS NOT PUT INTO MRI MODE DURING THE PATIENT¿S SCAN, AND THE PATIENT FELT DISCOMFORT DURING THE SCAN. THE HCP STATED THAT THE PATIENT¿S PROGRAMMER BATTERIES WERE DEAD, WHICH IS WHY MRI MODE WASN¿T ACTIVATED. THE HCP HAD NO FURTHER INFORMATION REGARDING THE EVENT OR THE PATIENT. THEY NOTED THAT IT HAPPED AROUND 2 MONTHS AGO. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED. INDICATION FOR USE IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1268979 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1