BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 18155382 · Received November 16, 2023

    Report

    Report Number
    2182207-2023-02486
    Event Type
    Injury
    Date Received
    November 16, 2023
    Date of Event
    September 13, 2023
    Report Date
    November 16, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_INS_STIMULATOR (SERIAL: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE PRODUCT ID NEU_INS_STIMULATOR (SERIAL: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE PRODUCT ID NEU_INS_STIMULATOR (SERIAL: UNKNOWN); PRODUCT TYPE: 0197-IMPLANTABLE NEUROSTIMULATOR; IMPLANT DATE ; EXPLANT DATE PRODUCT ID 3389 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ACTIVA; PRODUCT ID 3389 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE BRAND NAME ACTIVA; PRODUCT ID 3389 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE BRAND NAME ACTIVA; PRODUCT ID 3389 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE G2: CITATION: AUTHORS: SANJAY CHEEMA, FRANCISCA FERREIRA, OLGA PARRAS, SUSIE LAGRATA, SALWA KAMOURIEH, ASHKAN PAKZAD, LUDVIC ZRINZO, MANJIT MATHARU, HARITH AKRAM. ASSOCIATION OF CLINICAL AND NEUROANATOMICAL FACTORS WITH RESPONSE TO VENTRAL TEGMENTAL AREA DBS IN CHRONIC CLUSTER HEADACHE. AMERICAN ACADEMY OF NEUROLOGY 2023. 10.1212/WNL.0000000000207750 EARLIEST DATE OF PUBLICATION USED FOR DATE OF EVENT NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED. WITHOUT RETURN OF THE PRODUCT NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATIONS. D2: THESE DEVICES WERE USED FOR OFF-LABEL USE - CHRONIC CLUSTER HEADACHES 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

    SANJAY CHEEMA, FRANCISCA FERREIRA, OLGA PARRAS, SUSIE LAGRATA, SALWA KAMOURIEH, ASHKAN PAKZAD, LUDVIC ZRINZO, MANJIT MATHARU, HARITH AKRAM. ASSOCIATION OF CLINICAL AND NEUROANATOMICAL FACTORS WITH RESPONSE TO VENTRAL TEGMENTAL AREA DBS IN CHRONIC CLUSTER HEADACHE. AMERICAN ACADEMY OF NEUROLOGY. DOI: 10.1212/WNL.0000000000207750. DEEP BRAIN STIMULATION (DBS) OF THE VENTRAL TEGMENTAL AREA (VTA) IS A SURGICAL TREATMENT OPTION FOR SELECTED PATIENTS WITH REFRACTORY CHRONIC CLUSTER HEADACHE (CCH). WE AIMED TO IDENTIFY CLINICAL AND STRUCTURAL NEUROIMAGING FACTORS ASSOCIATED WITH RESPONSE TO VTA DBS IN CCH. METHODS THIS PROSPECTIVE OBSERVATIONAL COHORT STUDY EXAMINES CONSECUTIVE PATIENTS WITH REFRACTORY CCH TREATED WITH VTA DBS BY A MULTIDISCIPLINARY TEAM IN A SINGLE TERTIARY NEUROSCIENCE CENTRE AS PART OF USUAL CARE. HEADACHE DIARIES AND VALIDATED QUESTIONNAIRES WERE COMPLETED AT BASELINE AND REGULAR FOLLOW UP INTERVALS. ALL PATIENTS UNDERWENT T1-WEIGHTED STRUCTURAL MRI PRIOR TO SURGERY. WE COMPARED CLINICAL FEATURES USING MULTIVARIABLE LOGISTIC REGRESSION, AND NEUROANATOMICAL DIFFERENCES USING VOXEL-BASED MORPHOMETRY (VBM) BETWEEN RESPONDERS AND NON-RESPONDERS. RESULTS OVER A TEN-YEAR PERIOD, 43 PATIENTS (MEAN AGE 53 YEARS, SD 11.9), INCLUDING 29 MALES, WITH A MEAN DURATION OF CCH 12 YEARS (SD 7.4), WERE TREATED AND FOLLOWED UP FOR AT LEAST ONE YEAR (MEAN FOLLOW-UP DURATION 5.6 YEARS). OVERALL, THERE WAS A STATISTICALLY SIGNIFICANT IMPROVEMENT IN MEDIAN ATTACK FREQUENCY FROM 140 TO 56 PER MONTH (Z = -4.95, P <(><<)>0.001), ATTACK SEVERITY FROM 10/10 TO 8/10 (Z = -4.83, P <(><<)>0.001) AND DURATION FROM 110 TO 60 MINUTES (Z = -3.48, P <(> <<)>0.001). TWENTY-NINE (67.4%) PATIENTS EXPERIENCED >50% IMPROVEMENT IN ATTACH FREQUENCY AND WERE THEREFORE CLASSED AS RESPONDERS. THERE WERE NO SERIOUS ADVERSE EVENTS. THE MOST COMMON SIDE EFFECTS WERE DISCOMFORT OR PAIN AROUND THE BATTERY SITE (SEVEN PATIENTS) AND TRANSIENT DIPLOPIA AND/OR OSCILLOPSIA (SIX PATIENTS). THERE WERE NO DIFFERENCES IN DEMOGRAPHICS, HEADACHE CHARACTERISTICS, OR COMORBIDITIES BETWEEN RESPONDERS AND NON-RESPONDERS. VBM IDENTIFIED INCREASED NEURAL DENSITY IN NON-RESPONDERS IN SEVERAL BRAIN REGIONS, INCLUDING THE ORBITOFRONTAL CORTEX, ANTERIOR CINGULATE CORTEX, ANTERIOR INSULA, AND AMYGDALA WHICH WERE STATISTICALLY SIGNIFICANT (P <(><<)>0.001). DISCUSSION - VTA DBS SHOWED NO SERIOUS ADVERSE EVENTS, AND, ALTHOUGH THERE WAS NO PLACEBO CONTROL, WAS EFFECTIVE IN APPROXIMATELY TWO-THIRDS OF PATIENTS AT LONG-TERM FOLLOW UP. THIS STUDY DID NOT REVEAL ANY RELIABLE CLINICAL PREDICTORS OF RESPONSE. HOWEVER, NON-RESPONDERS HAD INCREASED NEURAL DENSITY IN BRAIN REGIONS LINKED TO PROCESSING OF PAIN AND AUTONOMIC FUNCTION, BOTH OF WHICH ARE PROMINENT IN THE PATHOPHYSIOLOGY OF CCH. REPORTED EVENTS: 1. IT WAS REPORTED THAT 1 PATIENT EXPERIENCED LEAD MIGRATION. 2. IT WAS REPORTED THAT 2 PATIENTS HAD AN INFECTION AND NEEDED THE PERIPHERAL HARDWARE REMOVED. 3. IT WAS REPORTED THAT 1 PATIENT HAD THEIR LEAD REMOVED DUE TO POST-SURGICAL NEUROPATHIC PAIN AROUND THEIR HEAD WOUND SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912021 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINS MHY MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Male Required Intervention