BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2872894 · Received December 13, 2012

    Report

    Report Number
    3004209178-2012-11814
    Event Type
    Injury
    Date Received
    December 13, 2012
    Report Date
    November 21, 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 39286-65 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 377645 LOT# V008353, IMPLANTED: 2008 (B)(6), PRODUCT TYPE LEAD PRODUCT ID 37752 LOT# SERIAL# (B)(4), PRODUCT TYPE RECHARGER PRODUCT ID 37743 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3708120 LOT# SERIAL# (B)(4), IMPLANTED: 2006 (B)(6), PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT WAS NOT GETTING COVERAGE ON HER RIGHT SIDE. WHEN TRYING TO PROGRAM FOR TROUBLESHOOTING, ALL STIMULATION WAS ON THE LEFT SIDE, REPROGRAMMING COULD NOT GET THE STIMULATION TO THE RIGHT SIDE. IMPEDANCES ON ALL 2X8 ELECTRODES WERE WITHIN NORMAL LIMITS. NO MALFUNCTIONS WERE SEEN OR CAUSE OF ISSUE WAS DETERMINED. PATIENT'S PHYSICIAN REMOVED LEFT TAIL OF THE IMPLANTED 2X8 PADDLE LEAD, INSERTED 1X8 OCTAD LEAD AND CONNECTED IT TO 0-7 PORT. 1X8 OCTAD LEAD WAS PLACED RIGHT OF MIDLINE AND THE PATIENT WAS GETTING APPROPRIATE STIMULATION ON BOTH SIDES NOW. NO DEVICES WERE EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37712

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention