BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 6230604 · Received January 6, 2017

    Report

    Report Number
    3004209178-2017-00398
    Event Type
    Malfunction
    Date Received
    January 6, 2017
    Date of Event
    November 1, 2016
    Report Date
    January 9, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT. IT WAS REPORTED THAT OVER THE PAST COUPLE OF MONTHS, THE PATIENT¿S STIMULATION HAS BEEN TURNING ITSELF OFF AND THEN BACK ON. IT WAS NOTED THAT WHEN THE STIMULATION COMES BACK ON, IT FEELS REALLY STRONG. THE REP NOTED THAT IMPEDANCES WERE CHECKED, AND WITHIN A RANGE OF 600-1090. THE PATIENT WAS FOLLOWING UP WITH THEIR HEALTHCARE PROVIDER AT A LATER DATE FOR A NEW BACK PAIN IN AN AREA DIFFERENT THAN WHAT IS BEING TREATED WITH THEIR IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS IMPLANTED FOR SPINAL PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURING REPRESENTATIVE (REP) INDICATED THAT NO DIAGNOSTIC ISSUES WERE DETECTED REGARDING THE PATIENT¿S STIMULATION TURNING ITSELF ON/OFF. HOWEVER, THE REP GAVE THE PATIENT A NON-ADAPTIVE STIMULATION GROUP THAT WAS AN EXACT COPY OF THE PATIENT¿S ADAPTIVE STIMULATION GROUP, IN CASE THE ADAPTIVE STIMULATION WAS THE CULPRIT. THE CAUSE OF THE ISSUE REMAINS UNKNOWN. THE PATIENT WAS TOLD TO KEEP TRACK OF WHEN STIMULATION TURNS ITSELF ON/OFF, AND TO USE NON-ADAPTIVE STIMULATION IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12258 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 59 YR