BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELLIS

    MDR report key: 12897398 · Received November 30, 2021

    Report

    Report Number
    3004209178-2021-17763
    Event Type
    Malfunction
    Date Received
    November 30, 2021
    Date of Event
    November 27, 2021
    Report Date
    November 30, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000315467
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT (PT) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS). THE REASON FOR CALL WAS PT STATES SHE NOTICED TWO DAYS AGO SOME OF HER PROGRAMS ARE MISSING AND ONLY HAS 4 OR 2 PROGRAMS IN THE GROUP. TROUBLESHOOTING WAS UNABLE TO BE PERFORMED AS PT WAS AT WORK AND DIDN'T HAVE HER EQUIPMENT. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PSS DIRECTED TO HCP AND OR BACK TO PSS TO TROUBLESHOOT FURTHER. PT SEES DR. DAVID KIM. NO PATIENT SYMPTOMS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1798673 INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97715 00763000315467

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female