BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 2932759 · Received January 29, 2013

    Report

    Report Number
    3004209178-2013-01069
    Event Type
    Malfunction
    Date Received
    January 29, 2013
    Report Date
    January 8, 2013
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3888-45, LOT# V304274, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3888-45, LOT# V305665, IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEADS IMPLANTED IN THE PATIENT'S MUSCLE CAUSED SPASMS. A LACK OF THERAPEUTIC EFFECT WAS NOTED AS WELL. IT WAS STATED THE EPIDURAL LUMBAR LEAD 'HELPS, BUT HAS LESS COVERAGE.' IT WAS STATED IT WAS ONLY HELPING THE RIGHT LEG. A LEAD MIGRATION WAS CONFIRMED VIA AN X-RAY TAKEN IN (B)(6) 2012. IT WAS STATED THE HEALTHCARE PROVIDER WAS CONSIDERING A REPLACEMENT OF THE EPIDURAL LUMBAR SYSTEM LEAD TO GAIN COVERAGE OF THE LEFT LEG. IT WAS NOTED THAT NO SURGERY WAS SCHEDULED AS OF THE DATE OF THIS REPORT. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38661 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MDT PUERTO RICO OPERATIONS CO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1