BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4241632 · Received November 10, 2014

    Report

    Report Number
    3004209178-2014-21268
    Event Type
    Injury
    Date Received
    November 10, 2014
    Report Date
    October 20, 2014
    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: 3777, LOT# V173898006, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3888, LOT# V162375, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 37081, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: PROGRAMMER, PATIENT .PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37082-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HAVING THE DEVICE EXPLANTED BECAUSE SHE HAD NOT BEEN GETTING THERAPY THAT SHE WAS EXPECTING. THE MANUFACTURER REPRESENTATIVE (REP) THOUGHT THE PATIENT STOPPED USING THE DEVICE ABOUT 3 YEARS AGO. THERE HAD BEEN A REVISION IN THE PAST WITH THE SAME DEVICE. ALL PRODUCTS HAD BEEN REMOVED EXCEPT FOR THE ANCHOR. THEY WERE HAVING TROUBLE GETTING IT OUT. IT WAS LATER REPORTED THAT EVERYTHING THAT WAS IMPLANTED WAS EXPLANTED. THE LAST TIME TROUBLESHOOTING WAS DONE WAS A FEW YEARS AGO. THE PATIENT WAS NOT GETTING ADEQUATE PAIN RELIEF SO THE IMPLANTABLE NEUROSTIMULATOR (INS) WENT DEAD. IT WAS NOTED THERE WAS A LACK OF EFFICACY. THE PATIENT RECOVERED FROM THE EXPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722757 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 00037 YR Required Intervention