BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 19343894 · Received May 17, 2024

    Report

    Report Number
    2182207-2024-02624
    Event Type
    Malfunction
    Date Received
    May 17, 2024
    Date of Event
    April 11, 2006
    Report Date
    August 21, 2024
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MBX
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D10: SECTION D INFORMATION REFERENCES THE MAIN0 COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID 3387; LOT# UNKNOWN; IMPLANTED: (B)(6) 2006; PRODUCT TYPE LEAD. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME ACTIVA; PRODUCT ID 3387 (LOT: UNKNOWN); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE ; EXPLANT DATE G2: CITATION: AUTHORS: SANDOVAL-BONILLA B. A., VARGAS M., NUNEZ M. A., PARPALEY Y., CODEIRO J. G., COSIO J. F., PEREZ DE LA TORRE R. A., GARCIA-MUNEZ L.. ADEQUATE CONTROL OF SEIZURES IN A CASE OF LEAD MIGRATION AND NEUROMODULATION OF THE POSTERIOR SYLVIAN JUNCTION: A CASE REPORT. SURGICAL NEUROLOGY INTERNATIONAL 15:124 2024. DOI: 10.25259/SNI_911_2023 B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING 'ADEQUATE CONTROL OF SEIZURES IN A CASE OF LEAD MIGRATION AND NEUROMODULATION OF THE POSTERIOR SYLVIAN JUNCTION: A CASE REPORT'. THE FOLLOWING MEDTRONIC DEVICES WERE USED IN THE STUDY: A 3387S DBS LEAD. REPORTED EVENT: ON (B)(6) 2006, ELECTRODE MIGRATION WAS CONFIRMED. POSTERIOR MIGRATION OF THE ELECTRODE WAS IDENTIFIED AT POSTERIOR SYLVIAN JUNCTION (PSJ) BY POSTOPERATIVE MRI 1 MONTH AFTER SURGERY. INITIATION OF STIMULATION WAS STARTED ON (B)(6) 2006. IN 2019, AN INVASIVE RECORDING WITH SEEG IMPLANTATION TO CHANGE AND OPTIMIZE ELECTRODE POSITION WAS PROPOSED TO CONFIRM OR RULE OUT A TEMPORAL OR POSTERIOR QUADRANT ORIGIN OF SEIZURES. HOWEVER, FURTHER INVASIVE EVALUATION WAS NOT CONSENTED BY THE PATIENT AND FAMILY DUE TO FAVORABLE CLINICAL RESULTS OBTAINED WITH THE PREVIOUS PSJ STIMULATION. FROM 2019 TO 2021, PARAMETERS WERE MODIFIED TO IMPROVE SEIZURE CONTROL. NEVERTHELESS, THE MOST FAVORABLE OUTCOME WAS OBTAINED WITH ORIGINAL PARAMETERS (2V-120 US-145 HZ, CONTACTS 0¿3 NEGATIVE, CASING POSITIVE) AND MAINTAINED TO THIS DAY.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING 'ADEQUATE CONTROL OF SEIZURES IN A CASE OF LEAD MIGRATION AND NEUROMODULATION OF THE POSTERIOR SYLVIAN JUNCTION: A CASE REPORT'. THE FOLLOWING MEDTRONIC DEVICES WERE USED IN THE STUDY: A 3387S DBS LEAD. AMONG PATIENT ADVERSE EVENTS/DEVICE PERFORMANCE ISSUES INCLUDED: POSTERIOR MIGRATION OF THE ELECTRODE WAS IDENTIFIED AT POSTERIOR SYLVIAN JUNCTION (PSJ) BY POSTOPERATIVE MRI 1 MONTH AFTER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2529046 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, THALAMIC, EPILEPSY, IMPLANTED MBX MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female "SEE H11...."| SEE H11...