BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9377829 · Received November 26, 2019

    Report

    Report Number
    3004209178-2019-22670
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169864238
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A HISTORY OF A 0/3 SHORT THAT WAS PRESENT BEFORE THEIR REPLACEMENT ON MONDAY. THE CALLER NOTED THAT THE 0/3 SHORT DID NORMALIZE AFTER AT THE TIME OF THE REPLACEMENT. TO THE CALLER¿S KNOWLEDGE THE 0/3 WAS NOT PROGRAMMED TOGETHER. THE CALLER THOUGHT THE C/0 WAS PROGRAMMED ON ONE SIDE BUT THEY WEREN¿T SURE. THE CALLER THOUGHT THE SHORT HAD EXISTED OVER A YEAR. ON (B)(6) 2019, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP). THE REP STATED THAT THE IMPEDANCE TEST SHOWED THAT 0 & 1 HAS AN OPEN CIRCUIT AT 11200 OHMS, AND PATIENT WAS PROGRAMMED ON GROUP A 1+0-. HCP CREATED ANOTHER A GROUP B USING 2+1-. PATIENT WAS BEING PROGRAMMED IN CONSTANT CURRENT. THE POTENTIAL FOR CHARGE DENSITY BEING LESS LIKELY WHEN IMPEDANCE IS HIGHER WAS DISCUSSED. HCP ORDERED AN X-RAY TO SEE IF THEY DETECT ANYTHING. REP INTEND TO SEE PATIENT TO CHECK IMPEDANCE IN VARIOUS HEAD POSITIONS THIS WEEK; IMPEDANCE LOOKED FINE DURING INS REPLACEMENT, THUS REP THINKS THIS IS OCCURRING WHEN PATIENT IS UPRIGHT. THE POTENTIAL FOR LEAD/EXTENSION CONNECTION ISSUE WAS DISCUSSED. ONLY THE INS WAS REPLACED ON (B)(6). C3 447 OHMS C2 774 C1 726 C0 11800 03 11200 02 9936 01 12100 13 753 12 981 23 827 OHMS ON THE (B)(6) 2019, THE REP PROVIDED ADDITIONAL INFORMATION. REP INDICATED THAT AFTER THE INS REPLACEMENT POST OP HAD ELEVATED IMPEDANCES. THE PATIENT WAS PROGRAMED TO 1-2+ AND PER PATIENT'S HUSBAND DID NOT DO WELL, AND SWITCHED PATIENT BACK TO 1+0- WITH ELEVATED IMPEDANCES. PATIENT'S HUSBAND REPORTED 3.6MA (CONSTANT CURRENT PROGRAMMING) AND TURNED DOWN TO 3.2MA BUT WAS UNABLE TO TURN BACK UP WITHOUT GETTING AN OOR MESSAGE. IT WAS DISCUSSED THAT THIS WAS NORMAL WITH CONSTANT CURRENT AND DUE TO ELEVATED IMPEDANCES. IT WAS RECOMMENDED FOR REP TO PERFORM ADDITIONAL IMPEDANCE TESTING WITH PATIENT IN MULTIPLE POSITIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172528 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169864238

    Patients

    Seq Age Sex Outcome Treatment
    1