BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9301442 · Received November 8, 2019

    Report

    Report Number
    3004209178-2019-21409
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Report Date
    November 26, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529786
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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 · 0

    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 NOVEMBER. 4TH. C3 447 OHMS C2 774 C1 726 C0 11800 03 11200 02 9936 01 12100 13 753 12 981 23 827 OHMS ON THE 12TH NOVEMBER 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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090575 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601 00643169529786

    Patients

    Seq Age Sex Outcome Treatment
    1