BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 14316844 · Received May 7, 2022

    Report

    Report Number
    3004209178-2022-05801
    Event Type
    Malfunction
    Date Received
    May 7, 2022
    Date of Event
    April 1, 2022
    Report Date
    May 6, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR UNKNOWN INDICATIONS FOR USE. IT WAS REPORTED THAT SOMETIMES THE STIM SURGES UP AND DOWN EVEN WHEN THE INS IS FULLY CHARGED PT CLARIFIED THAT IT IS NOT PAINFUL STIMULATION BUT SHE CAN FEEL THE CHANGE IN STIM. - PT STATED SHE NOTICED IN HER MOVE TO GA (B)(6) 2022 THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. THE PATIENT'S RELEVANT MEDICAL HISTORY INCLUDED PT MENTIONED ON THE CALL THEY (IMPLANT HCP) DIDN'T PUT IT IN ON BOTH SIDES.(PSS UNDERSTOOD PT IS REFERRING TO THE LEAD WIRES) .THE HCP IN TN DID AN XRAY AND MADE PT AWARE THAT SHE ONLY HAS A LEAD ON ONE SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516719 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Female