BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 3883718 · Received June 19, 2014

    Report

    Report Number
    3004209178-2014-11799
    Event Type
    Malfunction
    Date Received
    June 19, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 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
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    AN OVERSTIMULATION SENSATION WAS REPORTED. THE PATIENT WAS USING HIS PP YESTERDAY TO ADJUST STIMULATION AND INCREASED, IT CONTINUED TO GO UP AND THEN IT WAS SO HIGH THAT HE FELT LIKE HIS LEGS WERE GOING TO COME OFF OF HIS BODY. WHEN THE PATIENT TRIED TO DECREASE OR TURN THE STIMULATION OFF USING THE PP, THE PP WOULD NOT RESPOND AND THEN THE SCREEN STARTED TO BLINK. THE PATIENT CHANGED THE BATTERIES BUT THAT DID NOT RESOLVE THE ISSUE. THE PATIENT EXPERIENCED THE OVERSTIMULATION FOR ABOUT 35 MINUTES WHEN HE REMEMBERED THAT HE COULD USE THE RECHARGER TO TURN THE STIMULATION OFF, WHICH IT DID. THE PP WOULD NOT POWER UP. ENERGIZER ADVANCED LITHIUM BATTERIES WERE BEING USED. THE PATIENT REMOVED THE BATTERIES TO CHECK FOR CORROSION, BUT THERE WAS NO CORROSION AND IT WAS VERIFIED THAT THE BATTERIES WERE PLACED CORRECTLY. DIFFERENT BATTERIES, (B)(6), WERE TRIED BUT THE PP STILL DID NOT POWER UP. DUE TO THE INCIDENT FROM YESTERDAY THE PATIENT WAS UNABLE TO USE STIMULATION LAST NIGHT AND AS A RESULT DID NOT SLEEP. IT WAS ADDITIONALLY REPORTED THAT THE PP DID NOT GET WET. ANOMALY APPEARS TO HAVE OCCURRED THROUGH PRODUCT USE. NO INDICATION OF PATIENT HARM. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360098 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