BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 2781228 · Received October 10, 2012

    Report

    Report Number
    3004209178-2012-09078
    Event Type
    Injury
    Date Received
    October 10, 2012
    Report Date
    September 18, 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 377875, LOT# V005100, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 377875, LOT# V005100, IMPLANTED: 2006 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) "FLIPPED" AND IT "PULLED THE LEADS OUT." IT WAS NOTED THAT THE PATIENT'S "SKIN THINNED" AND IT WAS REPLACED WITH A NEW DEVICE. IT WAS FURTHER NOTED THAT THE PATIENT'S LEADS MIGRATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THE PATIENT'S LEADS HAD MIGRATED ONE MONTH AFTER INITIAL IMPLANT.

    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