BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3821426 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09280
    Event Type
    Injury
    Date Received
    May 20, 2014
    Date of Event
    January 21, 2014
    Report Date
    June 6, 2014
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 7754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT GETS A METAL TASTE IN THEIR MOUTH AND A HEADACHE WHEN THEY TURN THEIR DEVICE ON. IT WAS NOTED NO ABNORMAL IMPEDANCE MEASUREMENTS WERE SEEN. IT WAS REPORTED THE PATIENT HAD A CT SCAN ON (B)(6) 2014 OF THEIR BRAIN AND THERE WAS NO HEMORRHAGE OR ACUTE TERRITORIAL INFARCT. IT WAS NOTED THIS EVENT DID NOT CAUSE HOSPITALIZATION AND NO INJURY OCCURRED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD STIMULATION IN THE WRONG LOCATION. IT WAS REPORTED THE PATIENT HAD A LEAD REVISION ON (B)(6) 2014 DUE TO A FALL AND THE DEVICE NOT PROVIDING THE COVERAGE THEY NEEDED. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WAS AWARE OF THE REVISION ¿A COUPLE WEEKS PRIOR¿ TO THE SURGERY. IT WAS FURTHER REPORTED THE PATIENT HAD FALLEN 1 TO 2 MONTHS PRIOR TO THE REVISION BUT THE EXACT DATE WAS UNKNOWN. IT WAS REPORTED THAT PRIOR TO THE REVISION THE PATIENT HAD BEEN HAVING HEADACHES WHEN THE STIMULATION WAS TURNED ON. IT WAS REPORTED THE PATIENT SHUT THEIR STIMULATION OFF AND THE HEADACHE WAS NOT AS BAD BUT WAS STILL PRESENT. IT WAS NOTED THE PATIENT THEN TURNED THEIR STIMULATION BACK ON VERY LOW AND THE HEADACHE CONTINUED BUT IT WAS NOT AS BAD AS WHEN IT WAS ON THEIR NORMAL SETTINGS. IT WAS FURTHER NOTED THE HEADACHES START AT THE BACK OF THEIR NECK AND TRAVELS UP TO THEIR HEAD AND THEN TO THEIR EYE. IT WAS ALSO REPORTED THE PATIENT HAS A METALLIC TASTES IN THEIR MOUTH WHEN THEIR STIMULATION WAS ON. IT WAS REPORTED THE PATIENT¿S LEADS ARE PLACED IN THE THORACIC AREA AND SINCE THEIR LEAD REVISION THEY HAVE BEEN GETTING GOOD COVERAGE. LASTLY, IT WAS NOTED THE PATIENT IS SCHEDULED TO SEE THEIR HEALTH CARE PROVIDER (HCP) FOR A CAT SCAN. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT¿S HEADACHES BEGAN ABOUT ONE MONTH AFTER BEING IMPLANTED. IT WAS NOTED THE REASON THE PATIENT FELL WAS UNKNOWN AND THE STIMULATION IN THE WRONG LOCATION WAS IN THEIR STOMACH AND BILATERALLY IN THEIR BACK AND DOWN BOTH LEGS TO THEIR TOES. IT WAS NOTED THAT NO HIGH IMPEDANCES WERE FOUND AND THE X-RAYS CONFIRMED THAT THE LEADS HAD MOVED AND REPROGRAMMING WAS NOT WORKING. IT WAS REPORTED THE PATIENT¿S LEADS WERE REVISED ON (B)(6) 2014 AND THE PATIENT WAS DOING GREAT FOR 2 MONTHS BUT THE HEADACHES AND METALLIC TASTE IN THEIR MOUTH WHEN THE STIMULATOR WAS ON.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S HEADACHES ARE CONTINUING. IT WAS REPORTED THE HEADACHES START AT THE BACK OF THEIR HEAD AND MOVE UP AND THEN THEY GET A STABBING SENSATION IN THEIR EYE. IT WAS NOTED THAT THE STIMULATION WAS OFF PRIOR TO SEEING THE MANUFACTURER REPRESENTATIVE AND WHEN TURNED BACK ON, ROUGHLY 4-5 MINUTES LATER THE PATIENT BEGAN TO FEEL PRESSURE IN THE BACK OF THEIR HEAD. IT WAS NOTED THE HEADACHES GO AWAY ROUGHLY 10 MINUTES AFTER STIMULATION IS TURNED OFF. IT WAS REPORTED THAT THE PATIENT HAS PREVIOUSLY HAD 1-2 TIMES OF BRIEF METALLIC TASTE IN THEIR MOUTH BUT THIS DISSIPATES QUICKLY. IT WAS REPORTED THE PATIENT'S STIMULATION IS IN THE TARGET AREA OF THEIR BACK AND LEGS. IT WAS NOTED THE PATIENT DID NOT HAVE A HISTORY OF HEADACHES PRIOR TO IMPLANT AND FEELS THEY CAN OCCUR EVENT WITH STIMULATION AMPLITUDE OF 0.02V BUT DOESN'T FEEL STIMULATION UNTIL THEY ARE AT 1.8V. IT WAS NOTED THE HEADACHES ONLY OCCUR WITH THE STIMULATION ON. IT WAS NOTED THAT REPROGRAMMING HAS NOT HELPED THUS FAR. IT WAS NOTED THAT ON THE DAY OF REPORT THE PROGRAMMING WAS CHANGED FROM A GUARDED CATHODE TO ++- ON (B)(6) 2010 ELECTRODES. IT WAS NOTED AN X-RAYS WAS PERFORMED OF THE LEADS AND THEY HAD NOT MOVED. IT WAS REPORTED IMPEDANCES WERE WITHIN NORMAL RANGE WITH A LOW OF 694 OHMS AND HIGH OF 892 OHMS. IT WAS NOTED ON THE DAY OR REPORTED THE PATIENT WAS HAVING A CT SCAN OF THEIR HEAD. INFORMATION OMITTED PERTAINING TO PATIENT'S MEDICAL HISTORY PRIOR TO IMPLANT THAT WAS NOT RELATED TO EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    299420 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 00037 YR Required Intervention