BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2772738 · Received October 4, 2012

    Report

    Report Number
    3004209178-2012-08898
    Event Type
    Injury
    Date Received
    October 4, 2012
    Report Date
    September 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875, LOT# V001117, IMPLANTED: 2006 (B)(6), EXPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708160, SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), EXPLANTED: 2009 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD EROSION ISSUE IN 2009. IT FULLY ERODED IN 2009 AND THE INS WAS REPLACED AT A NEW POCKET LOCATION. THE PATIENT HAD LOST 90 POUND OF WEIGHT DATE UNKNOWN OF START AND STOP OF WEIGHT LOSS, AND IF THIS COULD BE CAUSE OF ISSUE. (AND PREVIOUS EROSION ISSUE).

    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