BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4101580 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17357
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    May 25, 2014
    Report Date
    August 25, 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

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3708360, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3987A, LOT # N242368, IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING TELEMETRY ISSUES. AN IMPLANTABLE NEUROSTIMULATOR (INS) OVERDISCHARGE WAS SUSPECTED. THE MANUFACTURING REPRESENTATIVE WAS WITH THE PATIENT AT THE TIME OF THE REPORT AND WAS UNABLE TO COMMUNICATE WITH THE INS USING THE CLINICIAN PROGRAMMER, PATIENT PROGRAMMER AND RECHARGER. THE MANUFACTURING REPRESENTATIVE PERFORMED AN ANTENNA LOCATE (AL) AND GOT A RANGE OF 40-56. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED A FEW TIMES AND THE STIMULATION CAME ON FOR A SECOND AND ¿THAT WAS IT.¿ A NORMAL RECHARGE WAS ATTEMPTED AND THE REPRESENTATIVE SAW THE REPOSITION ANTENNA MESSAGE ON THE RECHARGER. THE PATIENT LAST RECHARGED SUCCESSFULLY IN THE BEGINNING OF (B)(6) 2014 AND NOTICED THAT COULD NOT CHARGE AT THE END OF MAY. THREE OR FOUR PMRS WERE PERFORMED AROUND (B)(6) 2014, BUT THEY NEVER GOT TO THE NORMAL RECHARGING SCREEN. THE PATIENT¿S BATTERY WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THE PATIENT WAS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583906 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 00051 YR Required Intervention