BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2920581 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00720
    Event Type
    Injury
    Date Received
    January 17, 2013
    Report Date
    December 27, 2012
    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
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE RECHARGER PRODUCT ID, 37742 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3708240 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID, 3487A-56 LOT# V022330, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-56 LOT# V020232, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-56 LOT# J0455370V, IMPLANTED: 2007-(B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3487A-56 LOT# V022330, IMPLANTED: 2007 (B)(6), PRODUCT TYPE LEAD. (B)(4). FINAL ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR FOUND NO ANOMALY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED ADVERSE POSITIONAL STIMULATION CHANGES AS WELL AS UNDESIRABLE CHANGES IN STIMULATION WITH SYMPTOMS OF INCREASED PAIN. THE SEVERITY OF THE PAIN WAS NOTED AS MILD. THE PATIENT WAS REPROGRAMMED ON (B)(6) 2012, (B)(6) 2012 AND (B)(6) 2012. THE PATIENT'S DEVICE WAS REPLACED AND THE ISSUE RESOLVED WITHOUT SEQUELAE ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25639 RESTORE ADVANCED STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37713

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention