BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 3092685 · Received May 3, 2013

    Report

    Report Number
    3004209178-2013-07295
    Event Type
    Injury
    Date Received
    May 3, 2013
    Report Date
    April 8, 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 MEDICAL PRODUCTS: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO FEEL STIMULATION ON (B)(6) 2013. ON THE FOLLOWING DAY, THE STIMULATION CAME BACK BUT THE PATIENT WAS "IN HORRIBLE PAIN AND EXPERIENCED SEIZURE-LIKE TWITCHING IN THE LEFT SIDE OF HER FACE AND LEFT EYE" WHICH LASTED FOR THE 30 MINUTE DURATION OF STIMULATION CYCLE. IT WAS STATED THAT THE PAIN WAS "NOT NERVE PAIN" BUT "PRESSURE IN THE HEAD." THE PATIENT REPORTEDLY HAD "LOCK EYE" AND COULD NOT OPEN HER EYE DUE TO THE PAIN. IT WAS STATED THAT THE CYCLE OF PAIN WHILE THE STIMULATION WAS ON "CONTINUED INTO SATURDAY BUT BY SATURDAY EVENING IT WAS BACK TO NORMAL." IT WAS NOTED THAT THE PATIENT'S HUSBAND CHECKED THE STIMULATION WHEN THE STIMULATION "SHOULD" HAVE BEEN ON AND NOTICED THAT THE VOLTAGE WAS NOT SHOWING ON THE PROGRAMMER. IT WAS REPORTED THE FOLLOWING DAY THAT THE PATIENT WAS "FRIED" AND "LOST HER VOICE." IT WAS LATER REPORTED THAT THE STIMULATION "SEEMED STRONGER THAN SHE HAD BEFORE," BUT NOTED THAT "SHE WASN'T IN ANY PAIN, IT JUST SEEMED HIGHER" ON (B)(6) 2013. ON THE FOLLOWING DAY, THE PATIENT DID NOT NOTICE "ANYTHING" AT 8 AM. HOWEVER, BY 2 PM, THE STIMULATION WAS "SO STRONG." IT WAS NOTED THAT THE DEVICE WAS PROGRAMMED AROUND 7.1 - 7.5 VOLTS BECAUSE THE PATIENT "WOULD HAVE A SEIZURE IF IT GOT AROUND 8.2 - 8.5 VOLTS." IT WAS STATED THAT THE EYE AND LIP ON THE LEFT SIDE BEGAN TWITCHING. THE PATIENT REPORTEDLY HAD FACIAL DAMAGE FROM A ROOT CANAL. THE PATIENT REPORTEDLY CALLED HER HEALTHCARE PROVIDER (HCP) AFTER EXPERIENCING THE EYE TWITCHING BECAUSE SHE THOUGHT IT ¿MIGHT BE THE ONSET OF A SEIZURE.¿ FIVE DAYS LATER, IT WAS REPORTED THAT AN "UNFORTUNATE RESPONSE" WAS TRIGGERED "A WEEK" PRIOR TO THE REPORT WHEN THE STIMULATION CAME ON AT 7.5 VOLTS. IT WAS NOTED THAT THE HCP COULD NOT ADJUST THE SETTINGS DOWN. IT WAS STATED THAT THE PATIENT "HAD BEEN RAMPING UP SLOWLY" AND AT ONE POINT, "EXPERIENCED A SEIZURE." IT WAS NOTED THAT "SOMETIMES" WHEN STIMULATION CAME ON, THE PATIENT DID NOT REALIZE IT. THE PATIENT REPORTEDLY EXPERIENCED A "SHOCKING OR JOLTING SENSATION" WHEN THE PATIENT'S SETTINGS WERE PROGRAMMED TO TURN ON FOUR TIMES A DAY. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT WITH THE HCP THE FOLLOWING DAY. TWO WEEKS LATER, IT WAS REPORTED THAT THERE WAS NO INJURY AND THE DEVICE WAS ON AND PERFORMED AS EXPECTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT WAS NOT SEEING THE ¿STATUS OF THE DEVICE¿ ON THE BOTTOM ROW OF THE PROGRAMMER. IT WAS NOTED THAT THE PATIENT¿S EYE WAS TINGLING AND SHE HAD A ¿LITTLE BIT OF HEAD PAIN.¿ IT WAS NOTED THAT THE PATIENT¿S EYE ¿STARTED TWITCHING HARD.¿ THE PATIENT REPORTED EXCRUCIATING PAIN LIKE ¿YOUR HEAD IS GOING TO EXPLODE.¿ ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S LIP WAS QUIVERING DURING HER SEIZURE-LIKE EPISODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194158 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 00063 YR Other