BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3863929 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11284
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 20, 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
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT COULD NOT FEEL THE STIMULATION FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) ¿RECENTLY¿. THE NURSE INTERROGATED THE PATIENT¿S DEVICE AND NOTED THAT THE INS WAS CHARGED. THE NURSE STATED THAT THEY TURNED THE INS VOLTAGE UP WITH THE PROGRAMMER UNIT BUT THE PATIENT COULD NOT FEEL THE STIMULATION. THE NURSE THEN TURNED THE DEVICE UP AGAIN AND ¿ALL OF A SUDDEN IT CAME ON¿ AND IT WAS ¿VERY STRONG¿. IT WAS THEN REPORTED THAT THE NURSE TURNED THE INS OFF AND BACK ON BUT THE PATIENT COULD NOT FEEL THE STIMULATION "AT ALL". IMPEDANCES WERE CHECKED AND IT SHOWED SEVERAL CONTACTS WERE HIGHER THAN 10,000 OHMS. IT WAS REPORTED THAT THE PATIENT DID NOT REPORT ANY FALLS BUT IT WAS NOTED THAT EXTENSIONS WERE USED IN THE INS SYSTEM. THE PATIENT WAS REFERRED TO THE IMPLANTING PHYSICIAN FOR A POSSIBLE REVISION AND BATTERY REPLACEMENT. FOLLOW UP INFORMATION RECEIVED ONE DAY LATER CONFIRMED THAT THE PATIENT WAS BEING REFERRED TO A SURGEON FOR EVALUATION AND REVISION. THERE WERE NO FURTHER ACTIONS TAKEN AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339001 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention