BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7569130 · Received June 5, 2018

    Report

    Report Number
    3004209178-2018-12577
    Event Type
    Malfunction
    Date Received
    June 5, 2018
    Date of Event
    June 1, 2018
    Report Date
    June 21, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994934604
    PMA / PMN Number
    H020007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURE REPRESENTATIVE (REP) REGARDING AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA, MOVEMENT DISORDERS. IT WAS REPORTED THAT THE REP WAS CHECKING IMPEDANCES PRIOR TO THE REPLACEMENT AND THEY GOT 0 & 3 ELECTRODE BEING LOW, BUT THEY COULDN'T RECALL HOW LOW. AFTER THE INS WAS REPLACED THE REP CHECKED THE IMPEDANCES AND 0-3 WERE OKAY, BUT FOR ELECTRODES 8-11 ONLY 8 WAS OKAY AND THE REST WERE HIGH. HCP SWITCHED THE PORT BUT THE IMPEDANCES DIDN'T FOLLOW, THUS HCP DECIDED TO OPEN A NEW BATTERY. REP TESTED IMPEDANCES AGAIN: C0 706 OHMS C1 24978, C2 868, C3 40K, 01 24500, 02 35K, 03 40K ,12 21700, 13 40K, 2 & 3 40K, C8 1189 THE REST WERE GREATER THAN 40K. HCP THEN SWITCHED THE PORTS AGAIN AND C & 3 AND C & 8 HAD GOOD IMPEDANCES, BUT ALL THE REST WERE GREATER THAN 40K. TECHNICAL SERVICES SUSPECTED THAT THE LEAD MIGHT NOT BE IN ALL THE WAY. THEY SUGGESTED THAT THE HCP TRIED TO WET THE LEAD AND TORQUE IT IN. HCP WERE ABLE TO GET THE LEAD IN AGAIN AND REP THEN TESTED IMPEDANCE AGAIN AND NOW BOTH SIDES WERE GOOD EXCEPT 0 & 3 BEING LOW, AS IT WAS PRIOR TO SURGERY. THE REP THEN DISCONNECTED. THERE WERE NO SYMPTOMS REPORTED. TROUBLESHOOTING RESOLVED THE HIGH IMPEDANCES. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCES (HIGH OR LOW) WAS NOT DETERMINED. IT WAS ALSO STATED THAT BECAUSE THE DEVICE SHOWED LOW IMPEDANCES ON COMBO OF 0 AND 3, SO NO ACTIONS WERE TAKEN. THE LOW IMPEDANCES HAD NOT BEEN RESOLVED. THE PATIENT'S WEIGHT WAS UNKNOWN. THE FIRST IMPLANTED DEVICE WAS DISCARDED BY THE FACILITY, AND THE UNUSED INS WAS RETURNED FOR ANALYSIS. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413834 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00613994934604

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR