BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3266542 · Received August 6, 2013

    Report

    Report Number
    3004209178-2013-12838
    Event Type
    Injury
    Date Received
    August 6, 2013
    Report Date
    July 10, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE EXTENSION; PRODUCT ID 37754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74002, LOT # N346974, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ADAPTER; PRODUCT ID 37714, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 74002, LOT # N202767, IMPLANTED: (B)(6) 2009, PRODUCT TYPE ADAPTER; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE EXTENSION; PRODUCT ID 3708260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE EXTENSION; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3998, LOT # L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3986A; LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # LA1828, IMPLANTED: (B)(6) 2002, PRODUCT TYPE LEAD; PRODUCT ID 3998, LOT # L92553, IMPLANTED: (B)(6) 2001, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD; PRODUCT ID 3986A, LOT # LB9304, IMPLANTED: (B)(6) 2004, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR OFF-LABEL INDICATION. THE INDICATION DEVICE USED FOR WAS OCCIPITAL NEURALGIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STIMULATOR ¿IN THE BACK OF MY HEAD¿ FOR MIGRAINES WAS NOT WORKING PROPERLY, WHICH STARTED ABOUT THREE OR FOUR DAYS AGO. IF THE PATIENT LAID DOWN AND TILTED HIS HEAD BACK TO THE POINT WHERE THE PLATE IN THE NECK STOPPED THE RANGE OF MOTION, THE PATIENT RECEIVED NORMAL STIMULATION. IF THE PATIENT HELD HIS HEAD NORMALLY, HE DID NOT GET RELIEF. THERE WERE NO FALLS OR TRAUMA REPORTED AND THE PATIENT HAD CONTACTED HIS DOCTOR. ADDITIONAL INFORMATION RECEIVED REPORTED THE DEVICE USED TO TREAT MIGRAINES WAS ¿ACTING UP.¿ THE PATIENT FELT STIMULATION STRONGLY ON THE RIGHT SIDE, BUT HARDLY ANYTHING ON THE LEFT SIDE. THE PATIENT TURNED THE STIMULATION UP TO 9V AND REACHED THE UPPER LIMIT. THE PATIENT STATED THAT CHANGES IN THE WEATHER MAY HAVE CAUSED THE ISSUE. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT FELT NO STIMULATION. THE TYPICAL SETTING WAS BETWEEN 5V AND 6V. THE PATIENT INCREASED STIMULATION UP TO 9.5V AND STIMULATION WAS FELT IN THE LEFT BACK OF THE HEAD TO BASE OF THE NECK, AND IT WAS UNCOMFORTABLE. THE PATIENT WAS COMFORTABLE AT 9.1V. ALL CONTACT PAIRS ¿SHOWED WITHIN RANGE.¿ IMPEDANCE MEASUREMENTS WERE NORMAL. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT FELT THERAPEUTIC STIMULATION AFTER AN IMPEDANCE TEST. THE PATIENT HAD A FOLLOW-UP WITH HIS HEALTHCARE PROFESSIONAL (HCP) TO CHECK SYSTEM AND DETERMINE LEAD PLACEMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE HCP WAS ¿STILL WORKING ON IT.¿ IT WAS NOTED THAT ONE LEAD IN THE LEFT OCCIPITAL WAS ¿NOT WORKING,¿ AND THE OUTCOME WAS NOT KNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    FOLLOW-UP INFORMATION RECEIVED REPORTED THAT X-RAYS AND A FLUOROSCOPIC EXAM WERE PERFORMED OF THE LEADS AND MULTIPLE REPROGRAMMING ATTEMPTS MADE. SEVERAL CONTACTS ON BOTH OCCIPITAL LEADS ARE NOT FUNCTIONING. REPLACEMENT SURGERY TO REMOVE THE OLD OCCIPITAL LEADS WAS PLANNED, BUT THE EXACT DATE WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367879 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Required Intervention