BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3863903 · Received June 10, 2014

    Report

    Report Number
    3004209178-2014-11281
    Event Type
    Injury
    Date Received
    June 10, 2014
    Report Date
    May 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3998, LOT# V008174, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3708240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: FA37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: RECHARGER.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT¿S PREVIOUS DEVICE THEY HAD FOR SIX YEARS WAS REPLACED BECAUSE THE LEADS MOVED AND THE IMPLANTABLE NEUROSTIMULATOR (INS) ¿QUIT DOING ITS JOB.¿ IT WAS NOTED THAT THIS HAPPENED IN (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341371 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention