BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE PRIME

    MDR report key: 3450084 · Received November 5, 2013

    Report

    Report Number
    3004209178-2013-20213
    Event Type
    Injury
    Date Received
    November 5, 2013
    Report Date
    October 18, 2013
    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 3998,# V010124, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 37742, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ¿TENTATIVELY SCHEDULED FOR A PROCEDURE TO MOVE HIS IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2013.¿ IT WAS NOTED THAT THE PATIENT LOST WEIGHT AND THIS HAD AFFECTED THE INS POCKET. IT WAS NOTED THAT THE PATIENT HAD A GRADUAL WEIGHT LOSS. IT WAS UNKNOWN WHEN THIS ISSUE BEGAN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE SURGERY TO CHANGE AND MOVE THE BATTERY TO A NEW POCKET LOCATION WAS SUCCESSFUL. IT WAS NOTED THAT THE PATIENT WAS MUCH HAPPIER AND WAS DOING GREAT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECIEVED REPORTED THAT BEFORE THE REVISION, THE INS POCKET SITE WAS PAINFUL BECAUSE THERE WAS NO FAT TO PAD IT. IT WAS NOTED THERE WAS NO OBSERVED DEVICE MALFUNCTION RELATING TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    569073 RESTORE PRIME STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37701

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention