BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3802561 · Received May 9, 2014

    Report

    Report Number
    3004209178-2014-08797
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    March 16, 2014
    Report Date
    May 5, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE RECHARGER; PRODUCT ID 3 7742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO THEIR DOCTOR¿S OFFICE ON (B)(6) AND A MANUFACTURER REPRESENTATIVE WAS PRESENT. THE REPRESENTATIVE DISCOVERED THAT THE PATIENT¿S STIMULATOR WAS SHUT OFF BUT THE PATIENT HAD NOT SHUT IT OFF. THE PATIENT HAD GONE THROUGH AIRPORT SECURITY 3 DAYS BEFORE THE REPORT AND THE SECURITY GATES MAY HAVE SHUT OFF THE IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT KNEW THE INS WAS NOT HELPING IN THE BACK OF THEIR HEAD. ADDITIONAL INFORMATION RECEIVED REPORTED THE CAUSE OF THE EVENT WAS CONFIRMED TO HAVE BEEN FROM WALKING THROUGH AIRPORT SECURITY. IT WAS REPORTED THE PATIENT MET WITH A MANUFACTURER REPRESENTATIVE WHO INTERROGATED THE SYSTEM AND WAS ABLE TO TURN IT BACK ON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281356 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00083 YR