BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6685790 · Received July 5, 2017

    Report

    Report Number
    3004209178-2017-14197
    Event Type
    Malfunction
    Date Received
    July 5, 2017
    Date of Event
    February 1, 2017
    Report Date
    July 5, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE IS APPROXIMATE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR SPINAL PAIN. IT WAS REPORTED THAT SOMETHING WAS GOING WRONG AND THE PATIENT WAS NOT SURE IF IT WAS THE MACHINE OR IF SOMETHING WAS GETTING WORSE IN THEIR BACK, HIPS, AND LEGS. THE PATIENT STATED THEY WERE HURTING SO BAD ALL THE TIME AND CONFIRMED THAT THE PAIN WAS THEIR TARGET PAIN. THE PATIENT CAN'T SLEEP AT NIGHT AND WAS SO TIRED EVERY DAY. THE PATIENT FELT STIM BILATERALLY FROM THE WAIST DOWN, WHICH IS WHERE THE STIM WAS SUPPOSED TO BE. THE PATIENT STATED THEY HAD A HORRIBLE CASE OF PNEUMONIA AND LOST GOBS OF WEIGHT. THE PATIENT SAID THEY LOST (B)(6) POUNDS AND COUGHED THEIR BRAINS OUT. THE PATIENT WONDERED IF THE WEIGHT LOSS AFFECTED THEIR DEVICE. THE PATIENT STATED THEY MAY SEEK A SECOND OPINION FROM A DIFFERENT HEALTHCARE PROVIDER. THE PATIENT ALSO NOTED THEY FELL AND BROKE THEIR BACK AND HAD SURGERY THAT MESSED THEM UP EVEN WORSE PRIOR TO THE DEVICE BEING IMPLANTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467605 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR