BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3923774 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12762
    Event Type
    Injury
    Date Received
    July 9, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 39565-30, 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 3708160, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2008 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT DEVELOPED AN INFECTION AND IT WAS UNKNOWN WHEN IT OCCURRED. THE COMPANY REPRESENTATIVE WAS ASKED ABOUT EXTENSION TO CONNECT TO A COMPETITIVE INS AND WAS TOLD OF EXPLANT DURING THE CONVERSATION. IT WAS CONFIRMED THAT THE INS WAS TAKEN OUT DUE TO INFECTION. THE CAUSE OF THE INFECTION WAS GUESSED TO BE DUE TO SOME SORT OF BACTERIA BUT THERE WAS NO FURTHER INSIGHT AS TO THE SOURCE OF THE BACTERIA OR STRAIN. THE PATIENT WAS CONSIDERING IMPLANT OF A NEW INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401525 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention