BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 8745223 · Received June 28, 2019

    Report

    Report Number
    3004209178-2019-12634
    Event Type
    Malfunction
    Date Received
    June 28, 2019
    Date of Event
    December 31, 2018
    Report Date
    July 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169781702
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 97745, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER'S REPRESENTATIVE. IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. THE PATIENT WAS REPROGRAMMED TO ADDRESS THE LACK OF RELIEF ISSUE AND THEY NOTED THAT THE IMPEDANCES DIDN'T INTERFERE WITH ANY OF THE PROGRAMMING. THE CAUSE OF THE PROGRAMMER BEING OFF AN HOUR WAS NOT DETERMINED. NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    538259 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00643169781702

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR