BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3971255 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13767
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Report Date
    July 8, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37754, SERIAL# (B)(4); PRODUCT TYPE RECHARGER PRODUCT ID 37746, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOCKING SENSATION (¿EPICENTER IN RIGHT LEG) FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WHICH OCCURRED ABOUT 2 WEEKS AGO WHICH CAUSED THEM TO FALL DOWN. THE PATIENT THEN TURNED OFF THE STIMULATION. IT WAS NOTED THAT THE ACTIVE GROUP A WAS ADAPTIVE STIMULATION (AS) ENABLED AND THAT THE PATIENT HAD NOT CHANGED POSITIONS AT THE TIME OF THE EVENT (PATIENT WAS TALKING TO SOMEONE OUTSIDE). IMPEDANCES MEASUREMENTS WERE GOOD AND THAT ELECTRODE MEASUREMENTS ON #9-15 SHOWED NO ABNORMAL RESULTS (ALL WITHIN 800-1200 RANGE WITH NO SHORTS NOTED). THE MANUFACTURER¿S REPRESENTATIVE SWITCHED THE PATIENT TO GROUP B FOR THEM TO USE. FOLLOW UP INFORMATION RECEIVED (B)(4) 2014 REPORTED THAT THE CAUSE OF THE PATIENT¿S SHOCKING WAS STILL NOT CLEAR. THE MANUFACTURER¿S REPRESENTATIVE REPROGRAMMED THE PATIENT¿S STIMULATION WHERE IT WAS NOTED THAT THEIR PAIN WAS REDUCED BY AT LEAST 50%. IT WAS ALSO REPORTED THAT X-RAYS WERE TAKEN AND THE LEAD COMPONENTS APPEARED TO BE FULLY INSERTED IN THE INS BATTERY. ALSO, THE POCKET WAS EVALUATED BY ULTRASOUND TO RULE OUT FLUID AND CHECKED OUT TO BE NORMAL. IN ADDITION, IMPEDANCES APPEARED NORMAL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446933 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00079 YR