BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ADVANCED

    MDR report key: 2752619 · Received September 20, 2012

    Report

    Report Number
    3004209178-2012-08323
    Event Type
    Injury
    Date Received
    September 20, 2012
    Report Date
    September 4, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT # V113343, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER; PATIENT PRODUCT ID (B)(4), SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3998, LOT# V113343, SERIAL# IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION; PRODUCT ID 3708340, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT COULD NOT FEEL STIMULATION ON PROGRAM 1 OR 2. THE PATIENT CHARGED THE INS THE 'OTHER DAY' AND THEN WANTED TO TURN IT UP THE NIGHT PRIOR TO REPORT. THE PATIENT WAS UNABLE TO FEEL THE STIMULATION. NO FALLS OR TRAUMAS WERE REPORTED. THE PATIENT WAS GOING TO HAVE AN EPIDURAL SHOT THE DAY AFTER REPORT. THE NEXT DAY IT WAS REPORTED 3 OF 8 ELECTRODES WERE BROKEN. A REVISION WAS BEING SET UP. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD WAS REPLACED ON (B)(6) 2012. IT WAS NOTED THAT "ALL WAS GOOD" AND THE PATIENT "WAS GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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