BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 4130408 · Received September 30, 2014

    Report

    Report Number
    3004209178-2014-18020
    Event Type
    Malfunction
    Date Received
    September 30, 2014
    Report Date
    September 9, 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 Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: EXTENSION; PRODUCT ID 7435, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE STOPPED WORKING 6 MONTHS PRIOR TO THE NOTIFIED DATE, BUT THEN WAS CLARIFIED THAT IT WAS STILL WORKING. THE CAUSE OF UNKNOWN OR POSSIBLE NORMAL BATTERY DEPLETION DUE TO THE IMPLANTABLE NEUROSTIMULATOR (INS) BEING 9 YEARS OLD. IT WAS RECOMMENDED THAT THEY TRY TO INTERROGATE THE BATTERY AND PERFORM IMPEDANCE TESTING. IF THE BATTERY WOULDN¿T RESPOND THEN THE BATTERY WOULD BE AT END OF SERVICE (EOS). IF THE BATTERY WOULD RESPOND, THERE MIGHT BE ENOUGH BATTERY TO RUN DIAGNOSTIC TESTS ON THE SYSTEM. THE DAY AFTERWARDS, THE DEVICE WAS SUCCESSFULLY REPROGRAMMED. IT WAS DETERMINED THAT THE DEVICE WAS AT 85-95% CAPACITY, AND AT 2.33 V. IT WAS ALSO DISCOVERED THAT ELECTRODE #2 WAS >4,000 OHMS. THE PATIENT HAD 2X4 PADDLE LEADS IN THE NECK AND HAD EXTENSIONS. ALL PAIRS ON #2 WERE >4,000 OHMS; 01 = 690; 03 = 690; 04 = ?; 05 = 1395; 06 = 1352; 07 = 690; 13 = 690; 14 = ?; 15 = 1395; 16 = ?; 17 = 690; 34 = ??; 35 = 1352; 36 = ??; 37 = 690; 45 = 1395; 46 = 1395; 47 = 1352; 56 = 1395; 57 = 1395; 67 = ??. IT WAS NOTED THAT THERE ELECTRODE #2 HAD NOT BEEN USED IN PROGRAMMING IN THE PAST, AND THEY HAVE BEEN USING 3 AND 7 IN ONE PROGRAM AND 1 AND 3 IN ANOTHER. IT WAS FURTHER NOTED THAT THE PATIENT HAD NO STIMULATION SENSATION AND THOUGHT THAT STIMULATION HAD STOPPED WORKING FOR HER. INS WAS INTERROGATED AND THEY SAW THAT THE VOLTAGE WAS TURNED WAY DOWN TO 0.3V AND THE PATIENT USUALLY HAD IT UP AT 1.3V. THE MANUFACTURING REPRESENTATIVE INCREASED THE STIMULATION USING AN 8840, AND THEN THE PATIENT FELT STIMULATION AGAIN IN THE AREA OF HER NECK AND DOWN TO HER FINGERS, WHERE SHE HAD STIMULATION BEFORE. AT 1.4V, THE STIMULATION WAS CAUSING THE PATIENT¿S ARM TO SHAKE AND STIMULATION WAS UNCOMFORTABLE FOR THE PATIENT, SO THE MANUFACTURING REPRESENTATIVE TURNED THE STIMULATION DOWN AGAIN TO 0V TO GIVE THE PATIENT A BREAK FROM STIMULATION FOR A MOMENT. THE PATIENT ALSO FELT NUMBNESS IN HER FINGERS FOR THE PAST 2 WEEKS WHEN THE PATIENT HAD THE SENSATION THAT STIMULATION WAS OFF OR NOT WORKING. IT WAS NOTED THAT THE PATIENT HAD A HISTORY OF SOME FALLS, BUT IT WAS INDICATED THAT THE FALLS WERE NOT RELATED TO THE SYSTEM AT ALL. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608842 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1