BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3374480 · Received September 27, 2013

    Report

    Report Number
    3004209178-2013-17117
    Event Type
    Injury
    Date Received
    September 27, 2013
    Report Date
    September 6, 2013
    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

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37082-20, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-56, LOT# V117138, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3487A-56, LOT# V104285, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 377660, LOT# V012086, IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION. THE PATIENT COULD NOT GET THE RECHARGER TO CONNECT WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) AND HADN¿T BEEN ABLE TO DO SO FOR TWO MONTHS. THE REPORTER STATED THAT THE PATIENT NEEDED HER DEVICE TO ¿WAKE UP¿. THREE DAYS LATER IT WAS INDICATED THAT THE PATIENT WAS SCHEDULED FOR AN APPOINTMENT WITH A MANUFACTURER¿S REPRESENTATIVE THE FOLLOWING DAY. IT WAS FURTHER REPORTED THAT THE INS COULDN'T BE RECHARGED AFTER MULTIPLE ATTEMPTS OF THE POR (POWER ON RESET), ALTHOUGH THE INFORMATION REASONABLY SUGGESTS THAT PMR (PHYSICIAN MODE RECHARGE) WAS IMPLIED. THE INS WOULD BE REPLACED IN THREE DAYS AFTER THE REPORT, ON 9/9/13. FIVE DAYS LATER IT WAS REPORTED THAT EVERYTHING WAS GOOD AFTER THE REPLACEMENT, THERE WERE NO IMPEDANCE ISSUES AND THE PATIENT HAD STIMULATION WHERE NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489949 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 00025 YR Required Intervention