BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2461640 · Received February 20, 2012

    Report

    Report Number
    3004209178-2012-01088
    Event Type
    Injury
    Date Received
    February 20, 2012
    Date of Event
    November 23, 2011
    Report Date
    January 25, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: LEAD MODEL 377775 LOT# V011607 IMPLANTED: (B)(6) 2008 EXPLANTED: UNK; LEAD MODEL 377775 LOT# N0040746 IMPLANTED: (B)(6) 2008 EXPLANTED: UNK; PROGRAMMER MODEL 37743 SERIAL# (B)(4); RECHARGER MODEL 37752 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT'S PHYSICIAN WANTED TO REMOVE THE NEUROSTIMULATOR IN ORDER TO TREAT AN "UNRELATED TO THERAPY" ISSUE. THE PATIENT INDICATED THAT THE THERAPY WAS NOT HELPING, SO THEY QUIT USING THE NEUROSTIMULATOR FOR A YEAR. DUE TO THE PATIENT STOPPING USE, THE NEUROSTIMULATOR BATTERY REACHED A STATE OF OVERDISCHARGE. THE PATIENT THEN DECIDED TO HAVE THEIR NEUROSTIMULATOR REMOVED. POST EXPLANT, IT WAS NOTED THAT THERE WAS NO INJURY TO THE PATIENT. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Required Intervention