BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 14523026 · Received May 27, 2022

    Report

    Report Number
    2182207-2022-00912
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 4, 2022
    Report Date
    March 6, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 37601, DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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

    SIMSEK ERDEM N, OZKAYNAK SS, CAKIN H, UCAR T. SURGICAL-RELATED AND HARDWARE-RELATED ADVERSE EFFECTS OF DEEP BRAIN STIMULATION: A RET ROSPECTIVE SINGLE-CENTER ANALYSIS. TURK NEUROSURG. 2021.10.5137/1019-5149.JTN.32559-20.4. ALL PATIENTS WHO UNDERWENT DBS ELECTRODE IMPLANTATION AT THE AKDENIZ UNIVERSITY HOSPITAL DURING THE LAST FIVE YEARS PARTICIPATED IN THIS STUDY. DEMOGRAPHIC INFORMATION (SEX, AGE, DIAGNOSIS, THE DURATION BETWEEN DIAGNOSIS AND SURGERY, COMORBID DISEASE) AND THE DATE OF SURGERY WERE COLLECTED FROM AN ELECTRONIC MEDICAL DATABASE. THE ADVERSE EFFECTS OF DBS WERE CLASSIFIED INTO TWO: SURGERY-RELATED AND HARDWARE-RELATED EFFECTS, WHICH WERE FURTHER SUBDIVIDED BASED ON WHETHER THEY OCCURRED INTRAOPERATIVELY, IN THE EARLY POSTOPERATIVE STAGE, OR OVER A LONG PERIOD TIME. REPORTED EVENTS: 5 PATIENTS HAD AN INFECTION REQUIRING SECOND SURGERY. 2 PATIENTS EXPERIENCED EROSION REQUIRING SURGICAL REPAIR.   ONE PATIENT EXPERIENCED HALLUCINATIONS, CONFUSION, WEAKNESS AND LEFT CENTRAL FACIAL HEMIPARESIS AND EYE PTOSIS. A CT SCAN REVEALED AN EDEMA WHICH WAS RESOLVED AFTER A FEW DAYS OF STEROIDS. ONE PATIENT HAD PNEUMOCEPHALUS AROUND THE IMPLANT SITE. THREE WEEKS AFTER A CT SCAN REVEALED A BILATERAL SUBDURAL HEMATOMA WHICH WAS SURGICALLY EVACUATED THROUGH THE BURR HOLES. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENT WITH ANY PREVIOUSLY REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2768843 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention "SEE H10...."