BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE

    MDR report key: 3393107 · Received October 8, 2013

    Report

    Report Number
    3004209178-2013-17611
    Event Type
    Malfunction
    Date Received
    October 8, 2013
    Report Date
    September 26, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377760, LOT # V002902, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT # V002342, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377760, LOT # J0546522V, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 399930, LOT # V005883, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 3708240, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE RECHARGER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT TO SEE HER HEALTHCARE PROVIDER (HCP) TO HAVE HER LEADS CHANGED. THE PATIENT WAS ¿NOT SURE¿ WHEN THE LEADS BROKE BUT THEY WERE ¿OK NOW.¿ 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
    510100 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1