BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 6890164 · Received September 25, 2017

    Report

    Report Number
    3004209178-2017-19982
    Event Type
    Injury
    Date Received
    September 25, 2017
    Date of Event
    August 30, 2017
    Report Date
    December 20, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURING REPRESENTATIVE INDICATING THE LACK OF THERAPY/IMPEDANCE ISSUE WAS DUE TO A FRACTURED LEAD.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER INDICATING THAT THE HIGH IMPEDANCE/SYMPTOMS WERE RESOLVED THROUGH LEAD REPLACEMENT.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA AND MOVEMENT DISORDERS. IT WAS REPORTED THE PATIENT HAD IMPEDANCES FOR MONTHS AND WAS NOT GETTING THERAPY. THE REP CHECKED THEM BEFORE AND THEY WERE HIGH AS WELL. IN THE OPERATING ROOM, THE INS AND EXTENSION WERE CHANGED, BUT THE SURGEON DIDN'T WANT TO CHECK THE IMPEDANCES WHILE IN THE OPERATING ROOM. NOW THAT THEY WERE POST OPERATION, EVERYTHING ASSOCIATED WITH THE LEFT SIDE WAS OVER 40,000, THE PORT THAT WAS SUPPOSED TO HAVE A PLUG IN IT WAS SHOWING SOME HIGH IMPEDANCES AND SOME WERE OVER 40 K. THE CALLER WAS NOT PRESENT WHEN THE SURGEON INSERTED THE EXTENSION INTO THE INS, BUT OTHERS HAVE TOLD THEM THAT IT SITS PROPERLY AND WAS PLUGGED IN CORRECTLY. IT WAS NOTED THAT NO FALLS OR TRAUMA WAS ASSOCIATED WITH THE HIGH IMPEDANCES THAT THE PATIENT HAS HAD FOR MONTHS. IT WAS REVIEWED THAT RUNNING THE BATTERY MAY HELP SOME OF THOSE IMPEDANCE VALUES COME DOWN. ALSO, IT WAS REVIEWED TO TRY TO OBTAIN IMAGING TO CONFIRM THE PORTS OR PROGRAM THE PATIENT TO SEE IF THEY WERE GETTING ANY THERAPY ON EITHER SIDE. IT WAS CONFIRMED THAT THE EXTENSION WAS PLUGGED INTO THE BOTTOM PORT AND ALSO THAT THE BRAIN LEAD WAS THE CAUSE OF THE HIGH IMPEDANCES. THE LEAD WAS TO BE REPLACED IN THE NEAR FUTURE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER VIA THE REP. THE PATIENT WAS CONCERNED BECAUSE THEY WERE RARELY NEEDED TO CHARGE, AND WHEN THEY DO IT TOOK ONLY 15-20 MINUTES TO GET TO FULL. THE THERAPY IMPEDANCE ONLY SHOWS HIGH AND 0.699 MA, IT DOESN'T SHOW OHMS. THE CALLER STATED THERE WAS A KNOWN ISSUE WITH THE LEAD. IT WAS REPORTED 9<(>&<)>10 4538 OHMS, 9 <(>&<)> 11 7938 OHMS, 8<(>&<)>10 ABOUT 12,000, 8<(>&<)>11, ABOUT 15,000 OHMS. IT WAS REVIEWED THAT THERE WAS LITTLE TO NO CURRENT LEAVING THE BATTERY. THE PATIENT WAS COMPARING IT TO THEIR PREVIOUS BATTERY WHERE SOMETIMES IT GOT SO THAT THE THERAPY TURNED OFF AND THEY FELT WORSE. IT WAS QUESTIONABLE WHETHER THE PATIENT WAS GETTING ANY THERAPY NOW. THE CALLER STATED THAT THE PATIENT WAS PROGRAMMED ON 9- 10- 11+. IT WAS REVIEWED THAT THEY MIGHT HAVE BETTER LUCK IF PROGRAMMED ON JUST 9 <(>&<)> 10 SINCE THE IMPEDANCE WAS ONLY 4,538 OHMS. THERE WAS A LEAD REVISION IN THE FUTURE, THE CALLER STATED. IT WAS STATED THAT THERE WAS A CHANGE IN RECHARGING, THE BATTERY WAS SO LOW IT TURNED THE THERAPY OFF AND THE PATIENT FELT WORSE, AND THE SYMPTOM RELIEF WAS QUESTIONABLE. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    670337 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention