BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3950434 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13366
    Event Type
    Malfunction
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3887-33, LOT# J0337545V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE LEAD; PRODUCT ID NEU_RECHARGER_ACC, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) QUIT WORKING AND THE PATIENT STOPPED FEELING STIMULATION ON THE THURSDAY PRIOR TO THE DATE OF THIS REPORT. IT WAS NOTED THAT THE PATIENT WOULD USUALLY CHARGE ONCE A MONTH. IT WAS NOTED THAT THE PATIENT HAD FALLEN TWICE. IT WAS NOTED THAT ONE FALL HAD OCCURRED ON THE THURSDAY PRIOR TO THIS REPORT AND THE OTHER ON THE SATURDAY PRIOR TO THIS REPORT. IT WAS STATED THAT THE INS HAD STOPPED WORKING BEFORE THE PATIENT FELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428263 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00046 YR