BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 3251991 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12412
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    July 3, 2013
    Report Date
    July 3, 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 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3487A-33, LOT# V129426, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013, PRODUCT TYPE EXTENSION; PRODUCT ID 3487A-33, LOT# V008876, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 3487A-33, LOT# J0102025V, IMPLANTED: (B)(6) 2001, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A REVISION DUE TO NOT HAVING GOOD COVERAGE. ALL THREE QUAD LEADS AND THE TWO BIFURCATED EXTENSIONS WERE REMOVED AND REPLACED WITH TWO OCTAD LEADS THAT DIRECTLY CONNECTED TO THE EXISTING INS. IT WAS NOTED THAT ONE OF THE QUADS THAT WAS REMOVED WAS VISIBLY FRACTURED ON THE END THAT FIT INTO THE EXTENSION. THE PATIENT HADN¿T REPORTED ANY FALLS OR TRAUMA, AND IT WAS REPORTED THAT THE PATIENT WAS GETTING STIMULATION COVERAGE; JUST NOT AS GOOD AS SHE WANTED. THE INITIAL PLAN HAD BEEN TO REVISE AND ADJUST THE LEAD PLACEMENT, BUT ONCE THEY GOT IN THERE AND DID TESTING THEY FOUND THE FRACTURE AND HIGH IMPEDANCES. IT WAS LATER REPORTED THAT FOLLOWING THE PROCEDURE THE PATIENT WAS RECEIVING EFFECTIVETHERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352624 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 00073 YR Required Intervention