BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR

    MDR report key: 6063449 · Received October 28, 2016

    Report

    Report Number
    3007566237-2016-03769
    Event Type
    Injury
    Date Received
    October 28, 2016
    Date of Event
    April 29, 2009
    Report Date
    November 4, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    D2/G5: PLEASE NOTE THAT THIS DEVICE WAS USED IN AN OFF-LABEL MANNER AS IT WAS IMPLANTED FOR DEPRESSION. 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

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    SUPPLEMENTAL REPORT INITIATED TO CORRECT "ADVERSE EVENT <(>&<)> PRODUCT PROBLEM". 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

    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. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. 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

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    WILLIAMS, N.R., SHORT, E.B., HOPKINS, T., BENTZLEY, B.S., SAHLEM, G.L., PANNU, J., SCHMIDT, M., BORCKARDT, J.J., KORTE, J.E., GEORGE, M.S., TAKACS, I., NAHAS, Z. FIVE-YEAR FOLLOW-UP OF BILATERAL EPIDURAL PREFRONTAL CORTICAL STIMULATION FOR TREATMENT-RESISTANT DEPRESSION. BRAIN STIMULATION. 2016. DOI: 10.1016/J.BRS.2016.06.054. SUMMARY: TO EXAMINE THE LONG-TERM SAFETY AND EFFICACY OF EPIDURAL PREFRONTAL CORTICAL STIMULATION (EPCS) OF THE FRONTOPOLAR CORTEX (FPC) AND DORSOLATERAL PREFRONTAL CORTEX (DLPFC) FOR TREATMENT OF TREATMENT-RESISTANT DEPRESSION (TRD). REPORTED EVENTS: PATIENT 1: A (B)(6) FEMALE PATIENT WITH EPIDURAL PREFRONTAL CORTICAL STIMULATION (EPCS) FOR DEPRESSION WAS HOSPITALIZED ((B)(6) 2009) FOR AN ATTEMPT TO OVERDOSE ON XANAX AND KLONOPIN. IT WAS FOUND THAT BOTH IMPLANTABLE NEUROSTIMULATORS (INSS) WERE IN THE OFF POSITION; THEY WERE STABILIZED, THE INSS REACTIVATED AND THE PATIENT DISCHARGED FROM THE HOSPITAL, BUT THEY RETURNED 3 DAYS LATER WITH RETURNED SUICIDAL IDEATION AND A PLAN TO CUT THEMSELVES. THE AUTHORS FELT THIS WAS POSSIBLY RELATED TO THE ¿SUDDEN LOSS OF EFFECTIVENESS AND RELATIVELY RAPID RECOVERY¿ IN 2-3 WEEKS. NOTABLY THEY STATED THIS WAS FOUND AFTER THE PATIENT RETURNED FROM A TRIP TO (B)(6). THE AUTHORS REPORTED THAT PATIENTS WERE FIRST IMPLANTED WITH ITREL 3 OR SYNERGY DEVICES, ULTIMATELY REPLACED WITH KINETRA AND/OR ACTIVA DEVICES, HOWEVER THE PRECISE TIMING OF THESE REPLACEMENTS REMAINS UNCLEAR. 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
    716455 STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L