BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 8823968 · Received July 24, 2019

    Report

    Report Number
    3007566237-2019-01647
    Event Type
    Injury
    Date Received
    July 24, 2019
    Date of Event
    June 5, 2019
    Report Date
    August 5, 2019
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 0913025 LOT# S2845-07 IMPLANTED: (B)(6) 2019 PRODUCT TYPE: LEAD. 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

    NO ADDITIONAL INFORMATION WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    OUTCOMES TO ADVERSE EVENT: OTHER: NERVE DAMAGE. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 0913025, LOT #: UNKNOWN, IMPLANTED: UNKNOWN. COMMON DEVICE NAME: DEVICE USED FOR OFF LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS CHRONIC PAIN. 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) OF A CLINICAL STUDY VIA A MANUFACTURING REPRESENTATIVE (REP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR CHRONIC PAIN. IT WAS REPORTED THAT THE PATIENT HAD LEFT EYEBROW DROOP SINCE THEIR IMPLANT PROCEDURE. IT WAS NOTED THIS INTERFERED WITH THEIR DRIVING BUT THEY WERE ABLE TO COMPENSATE. EVALUATION BY THE HCP DETERMINED THE PATIENT HAD LEFT ORBICULARIS OCULI WEAKNESS, THEY WERE ABLE TO CLOSE THEIR EYE COMPLETELY AND HAD NO MOVEMENT WITH EYEBROW RAISE, CONSISTENT WITH FRONTALIS PALSY. THEY DETERMINED IT WAS MOST LIKELY DUE TO STRETCH FROM SURGICAL RETRACTION TO IMPLANT THE LEFT ELECTRODE, AND IT MAY TAKE APPROXIMATELY 6 MONTHS TO SEE IMPROVEMENT HOWEVER IT SHOULD RECOVER. THE PATIENT WAS ADVISED TO FOLLOW UP IN 6 MONTHS TO REASSESS RECOVER. ADDITIONAL INFORMATION RECEIVED FROM A REP INDICATED NERVE INJURY WAS CLINICALLY SUSPECTED AND DIAGNOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    615834 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37604

    Patients

    Seq Age Sex Outcome Treatment
    1 Other