BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3813091 · Received May 15, 2014

    Report

    Report Number
    3004209178-2014-09028
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    September 19, 2013
    Report Date
    April 26, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3888-33, LOT # VA0A07Z, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3888-33, LOT # VA0A07Z, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # V042627V02, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE REPLACEMENT LEAD WORKED DURING THE REPLACEMENT SURGERY, BUT NOT IN THE RECOVERY ROOM. IT WAS NOTED STIMULATION COULD STILL NOT BE TURNED ON TWELVE DAYS AFTER SURGERY. IT WAS REPORTED A REVISION SURGERY WAS PERFORMED SEVEN WEEKS LATER AND THE LEAD WAS UNPLUGGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291220 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 00056 YR Required Intervention