BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4903040 · Received July 9, 2015

    Report

    Report Number
    3004209178-2015-13078
    Event Type
    Injury
    Date Received
    July 9, 2015
    Report Date
    June 17, 2015
    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
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3778-75, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3550-29, LOT# N172485, IMPLANTED: 2008 (B)(6); PRODUCT TYPE ACCESSORY PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3778-75, SERIAL# (B)(4) IMPLANTED: 2008 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 3 778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3550-29, LOT# N172485, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT CHARGING PAST 1/2 WAY. MULTIPLE ERROR CODES WERE REPORTED; 375, 380, AND 365 WERE REPORTED. THE INS RECHARGER (INSR) WAS ALSO SHUTTING OFF ON ITS OWN OR IT WOULD BE SEARCHING FOR SOMETHING. THE PATIENT ATTEMPTED TO CHARGE THE DAY PRIOR TO THIS REPORT AND IT WOULDN'TGO PAST THE 1/2 BAR. THEY CHARGED FOR 4 HOURS AND IT WAS ONLY 1/2 CHARGED WITH ALL COUPLING BARS. IT WAS CONFIRMED THAT THE PATIENT WAS READING THE BATTERY ICON CORRECTLY. IT WAS SUGGESTED TO CONTINUE CHARGING AND SEE IF IT WENT OVER. FOLLOW-UP WAS PERFORMED TO DETERMINE IF ANY TROUBLESHOOTING HAD OCCURRED, IF A CAUSE HAD BEEN DETERMINED, IF ANY INTERVENTION WAS REQUIRED, IF THE ISSUE WAS RESOLVED, AND IF THE PATIENT HAD ANY FURTHER CONCERNS. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED. ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE PRIOR IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED. THE PATIENT NOTED THAT THE REPLACEMENT WAS NOT PREMATURE AND THAT THE INS WAS REPLACED BECAUSE IT WAS "SO OLD" AND SHE KEPT GETTING CODES WHEN SHE WAS RECHARGING. THIS WAS NOTED TO HAVE OCCURRED THREE TO FOUR OR MAYBE FIVE MONTHS PRIOR TO THE REPLACEMENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT COVERING THE PATIENT¿S PAIN. THE INS WAS BEING REPLACED DUE TO BATTERY ISSUES. IT WAS THOUGHT BECAUSE, THE PATIENT USED IT SO MUCH AND STIMULATION WAS ON 2 VOLTS AND WAS 8 VOLTS AT THE TIME OF THIS REPORT. THE DATE FOR REPLACEMENT WAS NOTED TO BE 2015 (B)(6). THE INS WAS NOT COVERING HER PAIN AREA ¿LIKE ONE OR TWO OF THE LEADS ARE NOT WORKING AT ALL.¿ NO FALLS OR TRAUMA OCCURRED. FOLLOW-UP WAS PERFORMED TO DETERMINE IF ANY TROUBLESHOOTING HAD OCCURRED, IF A CAUSE HAD BEEN DETERMINED, IF ANY INTERVENTION WAS REQUIRED, IF THE ISSUE WAS RESOLVED, AND IF THE PATIENT HAD ANY FURTHER CONCERNS. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444934 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