BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 9106019 · Received September 23, 2019

    Report

    Report Number
    3004209178-2019-18207
    Event Type
    Malfunction
    Date Received
    September 23, 2019
    Date of Event
    September 17, 2019
    Report Date
    November 19, 2020
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MRU
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    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.

    Additional Manufacturer Narrative · 1

    PMA: DYSTONIA (MRU; H020007) IS AN OFF-LABEL INDICATION FOR USE OF THE ACTIVA 37612 IMPLANTABLE NEUROSTIMULATOR IN THE UNITED STATES. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DYSTONIA. IT WAS REPORTED THAT ALL ELECTRODE COMBINATIONS INVOLVING CONTACT 8 HAD HIGH IMPEDANCES. ALL MEASUREMENTS INTRA-OPERATIVELY AND POST-OPERATIVELY WERE WITHIN NORMAL RANGES. THE PHYSICIAN TESTING THE ELECTRODE IMPEDANCE AT 3V WITH THE PATIENT'S HEAD IN TWO DIFFERENT POSITIONS, AND BOTH TIMES ELECTRODE 8 READ HIGH IMPEDANCE. THE PHYSICIAN CHANGED THE PROGRAMMING ELECTRODE FROM 8 & 9 TO 9 & C. THE ISSUE WAS NOT CONSIDERED RESOLVED. IT WAS REPORTED THE CAUSE OF HIGH IMPEDANCE WAS NOT DETERMINED AND NO FURTHER ACTION WAS PLANNED BY THE PHYSICIAN. IT WAS ALSO NOTED THAT PRIOR TO IMPLANT THERE WAS CONCERN OVER A CHEST IMPLANT (WHICH THE PHYSICIANS WENT AHEAD WITH) DUE TO THE PATIENT USING A H HARNESS FOR ACTIVITIES AND HOW THEY SIT IN THEIR WHEELCHAIR AND THEY BELIEVED THERE COULD BE A RISK OF FRICTION OVER THE INS. AN X-RAY WAS PERFORMED AND LOOKED FINE. NO PATIENT SYMPTOMS/COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    900870 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC PUERTO RICO OPERATIONS CO. 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR