BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 9941966 · Received April 8, 2020

    Report

    Report Number
    2182207-2020-00122
    Event Type
    Injury
    Date Received
    April 8, 2020
    Date of Event
    February 17, 2020
    Report Date
    April 8, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. AGE. THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(4).

    Description of Event or Problem · 1

    LAHTINEN MJ, HAAPANIEMI TH, KAUPPINEN MT, SALOKORPI N, HEIKKINEN ER, KATISKO JP. A COMPARISON OF INDIRECT AND DIRECT TARGETED STN DBS IN THE TREATMENT OF PARKINSON'S DISEASE-SURGICAL METHOD AND CLINICAL OUTCOME OVER 15-YEAR TIMESPAN. ACTA NEUROCHIR (WIEN). 2020. 1 0.1007/S00701-020-04269-X SUMMARY: DEEP BRAIN STIMULATION (DBS) IN THE SUBTHALAMIC NUCLEUS (STN) IS USED IN ADVANCED PARKINSON¿S DISEASE (PD) FOR REDUCING MOTOR FLUCTUATIONS AND THE SIDE EFFECTS OF ANTIPARKINSONIAN MEDICATION (APM). THE DEVELOPMENT OF NEUROIMAGING HAS ENABLED THE DIRECT TARGETING OF THE STN. THE AIM OF THIS STUDY IS TO EVALUATE THE OUTCOME IN PATIENTS WITH PD USING STN DBS WHEN CHANGING FROM ATLAS-BASED INDIRECT TARGETING METHOD (ITM) TO DIRECT MRI-BASED TARGETING (DTM) ASSUMING DTMIS SUPERIOR. IDENTIFIED EVENTS: 2 PATIENTS HAD AN EARLY SURGICAL SITE INFECTION FOLLOWED BY SURGICAL REVISION WITH PARTIAL OR TOTAL DBS REMOVAL AND CESSATION OF THE STIMULATION. BOTH OF THE PATIENTS WERE RE-IMPLANTED SUCCESSFULLY FOLLOWING ANTIBIOTIC TREATMENT. 1 PATIENT SUFFERED FROM A TECHNICAL FAILURE OF THE DBS DEVICE, WHICH WAS NOTED AS BEING A LEAD FRACTURE FOLLOWED BY CESSATION OF THE STIMULATION OR SELECTION OF NON-OPTIMAL ACTIVE CONTACT. THE PATIENT WAS RE-IMPLANTED SUCCESSFULLY BUT 12-MONTH EVALUATION WAS EXCEEDED. 1 PATIENT SUFFERED FROM A TECHNICAL FAILURE OF THE DBS DEVICE, WHICH WAS NOTED AS BEING CONTACT DAMAGE FOLLOWED BY CESSATION OF THE STIMULATION OR SELECTION OF NON-OPTIMAL ACTIVE CONTACT. THE PATIENT GOT A SATISFACTORY RESPONSE TO TREATMENT BY ALTERING THE PROGRAMMING. 1 PATIENT SUFFERED FROM POSTOPERATIVE UNILATERAL CHRONIC SUBDURAL HEMATOMA, WHICH DID NOT REQUIRE AND SURGICAL INTERVENTION NOR DID IT AFFECT THE CLINICAL OUTCOME. 1 PATIENT SUFFERED FROM POSTOPERATIVE ACUTE HEMORRHAGE ALONGSIDE THEIR UNILATERAL ELECTRODE. THIS CAUSED A SLIGHT TRANSIENT CONFUSION, WHICH DID NOT AFFECT THE CLINICAL ASSESSMENT. 1 PATIENT SUFFERED FROM POSTOPERATIVE ACUTE HEMORRHAGE ALONGSIDE THEIR BILATERAL ELECTRODE. THIS PATIENT HAD A SUBCLINICAL VITAMIN K DEFICIENCY DIAGNOSED AFTER POSTOPERATIVE EVALUATION. THE FOLLOWING DEVICE SPECIFICS WERE PROVIDED: LEAD MODEL 3389.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398874 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention