BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 14522681 · Received May 27, 2022

    Report

    Report Number
    2182207-2022-00907
    Event Type
    Injury
    Date Received
    May 27, 2022
    Date of Event
    April 4, 2022
    Report Date
    May 27, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    PJS
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. 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 ONE PATIENT DEVELOPED STATUS EPILEPTICUS. MEDICAL TREATMENT RESOLVED THE SEIZURES. A CT SCAN REVEALED HYPODENSITY OF AN EDEMA AROUND THE LEAD. 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
    2711214 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR ESSENTI PJS MEDTRONIC NEUROMODULATION 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Other