BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 4152915 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18506
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 19, 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
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3550-09, LOT# LB2578, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3887-33, LOT# J0205050V, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD. PRODUCT ID: 3708360, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A RECHARGEABLE IMPLANTABLE NEUROSTIMULATOR (INS) BUT IT ¿WASN¿T FOR THEM¿. THEY NOTICED WHEN THE IMPLANT WAS ¿STARTING TO GO¿ THEY WOULD HEAR A HUMMING IN THEIR EAR. THE HUMMING WAS NOT CONSTANT BUT WAS PRETTY REGULAR. THE PATIENT THEN HAD THEIR INS REPLACED IN (B)(6) 2011 AND WHEN IT WAS REPLACED THEY STOPPED HEARING THE HUMMING. THE NEW IMPLANT WAS PLACED ¿UP UNDER THEIR RIB CAGE¿ ON THEIR LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632029 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 Required Intervention