BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3143361 · Received June 3, 2013

    Report

    Report Number
    3004209178-2013-08572
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    May 15, 2013
    Report Date
    May 15, 2013
    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 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3776-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 37746, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE WOUND WASN'T CLOSED PROPERLY AND IT OPENED UP. IT WAS STATED A LOOP OF ONE OF THE LEADS WAS STICKING OUT AND THE ANCHOR WAS STILL INTACT AND IN ITS ORIGINAL LOCATION. REPORTEDLY, THE PATIENT WAS BROUGHT INTO THE OPERATING ROOM ON (B)(6) 2013 @ 5:30PM AND THE WOUND ¿LOOKED FINE.¿ IT WAS NOTED THE HEALTHCARE PROVIDER (HCP) CLEANED IT OUT AND SENT SOME TISSUE TO BE CULTURED. IMAGES SHOWED THE LEADS DIDN'T MOVE AND THE PATIENT WAS HAPPY WITH THE PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245167 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention