BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 7165757 · Received January 4, 2018

    Report

    Report Number
    3004209178-2018-00257
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    November 1, 2017
    Report Date
    January 4, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00643169109483
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR (INS) FOR SPINAL PAIN. INFORMATION WAS REPORTED THAT WHEN THE PATIENT IS LYING DOWN AT NIGHT THE STIMULATION IS SO STRONG SHE HAS TO TURN IT OFF AT NIGHT. THE PATIENT STATED WHEN LYING DOWN THE STIMULATION IS TOO MUCH WHERE SHE HAD TO TURN THE STIMULATION OFF BECAUSE IT WILL NOT LOWER. PATIENT STATED WHEN LYING DOWN THE STIMULATION GOES TO 7.8V. THE PATIENT STATED WHEN SHE TRIES TO LOWER THE STIMULATION IT WILL NOT LOWER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9403 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 97714 00643169109483

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR