BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3171743 · Received June 16, 2013

    Report

    Report Number
    3004209178-2013-10425
    Event Type
    Injury
    Date Received
    June 16, 2013
    Report Date
    May 28, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3776-45, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), EXPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), PRODUCT TYPE RECHARGER PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: 2008-(B)(6), (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEAD WAS REPOSITIONED ON (B)(6)-2010. IT WAS NOTED THAT THE PATIENT WAS EXPERIENCING ¿TENDERNESS¿ AT THE LEAD SIGHT. IT WAS FURTHER NOTED THAT ABOUT A WEEK LATER, THE PATIENT¿S IMPLANTABLE NEUROSTIMULATOR (INS) AND LEADS WERE EXPLANTED DUE TO AN INFECTION AT THE INCISION SITE. IT WAS NOTED THAT THE PATIENT¿S SYMPTOMS INCLUDED ¿RED PUFFINESS¿ AND ¿PUS DRAINAGE AT THE INCISION SITE.¿ IT WAS FURTHER NOTED THAT THE PATIENT RECOVERED WITHOUT SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272730 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 Required Intervention