BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3113321 · Received May 15, 2013

    Report

    Report Number
    3004209178-2013-07678
    Event Type
    Injury
    Date Received
    May 15, 2013
    Report Date
    April 22, 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
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3550-39, LOT# N344318, IMPLANTED: (B)(6) 2012, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A REVISION IN FEBRUARY, DATE UNKNOWN, TO REPLACE A LEAD BECAUSE THE PATIENT WAS UNABLE TO FEEL STIMULATION ON THE LEFT SIDE DUE TO AN ACCIDENT WHERE THE PATIENT'S LEAD HAD MOVED AND GOTTEN 'MANGLED' WITH THE OTHER LEAD. IT WAS ALSO REPORTED THE PATIENT HAD SCAR TISSUE. IT WAS NOTED ONLY ONE OF THE LEADS WAS REPLACED. IT WAS ALSO NOTED THAT STIMULATION HAD ONLY HELPED WITH THE 'SENSITIVITY,' IT DID NOT HELP WITH THE PATIENT'S PAIN. SINCE THE REVISION THAT PATIENT HAD EXPERIENCED PAIN WHERE THE LEAD WAS PLACED WHICH STOPPED WHEN THE PATIENT TURNED STIMULATION OFF. IT WAS REPORTED AFTER THE REVISION IN (B)(6) THE PATIENT EXPERIENCED AN INCIDENT WHERE STIMULATION 'JUST STOPPED AND HE MOVED HIS BACK AND ALL OF A SUDDEN STIMULATION CAME BACK ON.' AN X-RAY WAS PERFORMED 2 WEEKS AFTER THE REVISION AND A MANUFACTURER REPRESENTATIVE CHECKED THE PATIENT'S DEVICE AND EACH PROGRAM AND NO ISSUES WITH THE LEADS WERE FOUND. IT WAS ALSO REPORTED AFTER IMPLANT THE PATIENT WAS DIAGNOSED WITH SLEEP APNEA AND COULD NOT HAVE "MUCH" SEDATION SO HE COULD FEEL EVERYTHING DURING THE REVISION. THE PATIENT WAS CONCERNED ABOUT HAVING TO UNDERGO ANOTHER REVISION. ADDITIONAL INFORMATION RECEIVED TWO DAYS LATER REPORTED THE PATIENT HAD AN X-RAY SEVERAL WEEKS PRIOR TO THIS REPORT AND THE LEAD 'LOOKED IN THE SAME POSITION AS IMPLANT.' IT WAS NOTED THE PATIENT'S PHYSICIAN HAD ORDERED ANOTHER X-RAY TO BE TAKEN THE WEEK OF THIS REPORT. IT WAS REPORTED AN IMPEDANCE CHECK SHOWED ONE CONTACT OUT OF RANGE BUT IT WAS NOTED THAT CONTACT WAS NOT USED IN THE ANY OF THE PATIENT'S PROGRAMS. THE PATIENT WAS EXPERIENCING UNCOMFORTABLE UPPER BACK PAIN WHEN THE STIMULATOR WAS TURNED UP TO A THERAPEUTIC LEVEL. IT WAS NOTED UP UNTIL THE WEEK OF THIS REPORT THE PATIENT WAS GETTING 'GOOD' PARESTHESIA TO HIS LEGS; HOWEVER THE EFFECTIVENESS IN RELIEVING HIS PAIN WAS LIMITED BY THE BACK PAIN. AT THE PATIENT'S LAST OFFICE VISIT HE REPORTED HE WAS NO LONGER GETTING STIMULATION IN HIS LEFT LEG AND STIMULATION WAS POSITIONAL WHEN HE MOVED HIS BACK IN CERTAIN WAYS. IT WAS NOTED MULTIPLE REPROGRAMMING SESSIONS HAD NOT BEEN ABLE TO RESOLVE THE ISSUE AND THE PATIENT'S PHYSICIAN WAS CONSIDERING REFERRING HIM TO A NEUROSURGEON FOR A LEAD REVISION. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT STARTED TO FEEL THE STIMULATION IN THEIR RECTUM AREA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214044 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention