BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12088876 · Received June 29, 2021

    Report

    Report Number
    2182207-2021-01150
    Event Type
    Injury
    Date Received
    June 29, 2021
    Date of Event
    May 10, 2021
    Report Date
    June 29, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO SHOW ATTACHED LITERATURE ARTICLE. 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

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3389 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3389, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. 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.

    Description of Event or Problem · 1

    RISK OF INFECTION AFTER DEEP BRAIN STIMULATION SURGERY WITH EXTERNALIZATION AND LOCAL-FIELD POTENTIAL RECORDINGS: TWELVE-YEAR EXPERI ENCE FROM A SINGLE INSTITUTION. LUCIA K. FELDMANN, WOLF-JULIAN NEUMANN, KATHARINA FAUST, GERD-HELGE SCHNEIDER, ANDREA A. KÜHN. DOI: 10.1159/000516150 ABSTRACT INTRODUCTION: DEEP BRAIN STIMULATION (DBS) HAS BEEN AN ESTABLISHED SURGICAL PROCEDURE IN THE FIELD OF FUNCTIONAL NEUROSURGERY FOR MANY YEARS. THE EXPERIMENTAL ELECTROPHYSIOLOGICAL METHOD OF LOCAL FIELD POTENTIAL (LFP) RECORDINGS IN POSTSURGICALLY EXTERNALIZED PATIENTS HAS MADE SUBSTANTIAL CONTRIBUTIONS TO THE BETTER UNDERSTANDING OF PATHOPHYSIOLOGIES UNDERLYING MOVEMENT DISORDERS. AS INTEREST IN LFP RECORDINGS FOR THE DEVELOPMENT OF IMPROVED STIMULATION STRATEGIES INCREASES, THIS STUDY¿S AIM WAS TO PROVIDE EVIDENCE CONCERNING SAFETY OF THIS RESEARCH METHOD, IN A MAJOR DBS CENTER. METHODS: WE RETROSPECTIVELY ANALYZED INCIDENCE AND INFECTION CHARACTERISTICS IN ADULT PATIENTS WHO UNDERWENT TWO-STAGED DBS SURGERY WITH TEMPORARY EXTERNALIZATION OF LEADS IN OUR CENTER BETWEEN JANUARY 2008 AND NOVEMBER 2019. WE FOCUSED ON WHETHER PATIENTS HAD PARTICIPATED IN LFP RECORDINGS, AND EVALUATED INCIDENCE OF INFECTIONS AT 3 MONTHS AND 1 YEAR AFTER THE SURGERY BASED ON MEDICAL RECORDS. INFECTION RATES WERE COMPARED TO MAJOR DBS STUDIES AND REPORTS FOCUSING ON THE RISK OF INFECTION DUE TO EXTERNALIZATION OF DBS LEADS. RESULTS WERE VISUALIZED USING DESCRIPTIVE STATISTICS. RESULTS: BETWEEN JANUARY 2008 AND NOVEMBER 2019, DBS SURGERY WAS PERFORMED IN 528 PATIENTS (389/139 PATIENTS IN THE LFP/NON-LFP GROUP), MAINLY FOR MOVEMENT DISORDERS SUCH AS PARKINSON¿S DISEASE (308), DYSTONIA (93), AND ESSENTIAL TREMOR (86). OF THE PATIENTS, 72.9% PARTICIPATED IN LFP RECORDINGS. THE INCIDENCE OF INFECTIONS IN THE ACUTE POSTSURGICAL PHASE (3 MONTHS) WAS 2.46% AND DID NOT DIFFER SIGNIFICANTLY BETWEEN THE LFP GROUP (1.8%) AND THE NON-LFP GROUP (4.32%). THE OVERALL INCIDENCE AFTER 1 YEAR AMOUNTED TO 3.6% (19 PATIENTS) WITH NO DIFFERENCE BETWEEN LFP/NON- LFP GROUPS. INCIDENCE RATES REPORTED IN THE LITERATURE SHOW A LARGE VARIETY (2.6¿10%), AND THE INCIDENCE REPORTED HERE IS WITHIN THE LOWER RANGE OF REPORTED INCIDENCES. DISCUSSION/ CONCLUSION: THIS STUDY DEMONSTRATES THAT DBS IS A SURGICAL PROCEDURE WITH A LOW RISK OF INFECTION IN A LARGE PATIENT COHORT. IMPORTANTLY, IT SHOWS THAT LFP RECORDINGS DO NOT HAVEA SIGNIFICANT EFFECT ON THE INCIDENCE OF INFECTIONS IN PATIENTS WITH EXTERNALIZATION. WITH A REPRESENTATIVE COHORT OF MORE THAN 380 PATIENTS PARTICIPATING IN LFP-RECORDINGS, THIS UNDERLINES LFP AS A SAFE METHOD IN RESEARCH AND SUPPORTS FURTHER USE OF THIS METHOD, FOR EXAMPLE, FOR THE DEVELOPMENT OF ADAPTIVE STIMULATION PROTOCOLS. REPORTED EVENTS: IT WAS REPORTEDTHAT 3.6% OF TOTAL PATIENTS (19/528) GOT INFECTIONS. 13 OF THESE INFECTIONS WERE WITHIN THE FIRST 3 MONTHS AFTER THE SURGERY. MOST INFECTIONS WERE CAUSED BY MOST INFECTIONS WERE CAUSED BY BACTERIA CLASSICALLY RESIDENT ON THE SKIN SUCH AS STAPHYLOCOCCUS AUREUS (40.9%), STAPHYLOCOCCUS EPIDERMIDIS (13.6%), STAPHYLOCOCCUS LUGDUNENSIS. (9.1%), STAPHYLOCOCCUS CAPITIS (4.5%), OR THE RESPIRATORY TRACT SUCH AS STREPTOCOCCUS SALIVARIUS (4.5%) AND MORAXELLA OLENSIS (4.5%), AS WELL AS 1 CASE OF PROTEUS MIRABILIS INFECTION. IN 3 CASES THE RELATION OF THE SSI TO A DETECTABLE INFECTIOUS AGENT IN MICROBIOLOGICAL EXAMINATION WAS NOT SUCCESSFUL. OF THE 18 PATIENTS, 11 RECEIVED A REIMPLANTATION (DBS LEADS AND NEUROSTIMULATOR: 4; NEUROSTIMULATOR: 4; DBS LEADS: 3) BETWEEN 2 AND 15 MONTHS LATER WITHOUT FURTHER COMPLICATIONS. THE REMAINING PATIENTS WERE PLANNED TO RECEIVE REIMPLANTATION, DECIDED AGAINST REIMPLANTATION, OR NEW CONTRAINDICATIONS HAD EVOLVED IN THE MEANTIME. ALL PATIENTS HAD EVENTUALLY RESOLVED ALL OF THEIR INFECTIONS. 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
    984733 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention "SEE H10...."