BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2842914 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10680
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 26, 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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7427, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR, PRODUCT ID 3998, LOT# LB7344, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377760, LOT# V001116, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377760, LOT# V001116, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PROGRAMMER, PATIENT PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. FOR USE BY USER FACILITY/IMPORTER (DEVICES ONLY). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD LEAD FRACTURE AND THE LEAD WAS REPLACED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED SINCE THEY WERE ALREADY GOING TO BE DOING A PROCEDURE. THE INS WAS REPLACED DUE TO NORMAL USE, THE PATIENT WAS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention