BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 15737286 · Received November 4, 2022

    Report

    Report Number
    2182207-2022-02057
    Event Type
    Injury
    Date Received
    November 4, 2022
    Report Date
    November 4, 2022
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: HUANG M, CHEN Q, WU S, ET AL. TREATMENT EFFICACY AND TECHNICAL ADVANTAGES OF TEMPORARY SPINAL NERVE ROOT STIMULATION COMPARED TO TRADITIONAL SPINAL CORD STIMULATION FOR POSTHERPETIC NEURALGIA. PAIN PHYSICIAN. 2022;25(6):E863-E873 LITERATURE ABSTRACT: THE STUDY AIMED TO DESCRIBE THE TECHNICAL FACTORS AND THE THERAPEUTIC EFFICACY OF TEMPORARY SPINAL NERVE ROOT STIMULATION (TSNRS) FOR PATIENTS WITH UNILATERAL PHN AND TO COMPARE THESE PARAMETERS WITH THOSE TREATED WITH TEMPORARY SPINAL CORD STIMULATION (TSCS). A2: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. A3: THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B3: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S PUBLICATION DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. B5: IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE REPORTED EVENTS 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. CONTINUATION OF D10: PRODUCT ID 3873 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE SCREENING DEVICE PRODUCT ID 3873 LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE SCREENING DEVICE PRODUCT ID NEU_ENS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE EXTERNAL NEUROSTIMULATOR SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3873, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: ; PRODUCT ID: 3873, SERIAL/LOT #: UNKNOWN, UBD: , UDI#: 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

    REPORTED EVENTS: 9 PATIENTS EXPERIENCED LOCAL WOUND INFECTION THAT RESOLVED WITHIN TWO WEEKS AFTER ELECTRODE REMOVAL. THE AUTHORS NOTED THAT IF THE INSERTION SITE SHOWED SIGNS OF WOUND INFECTION DURING THE POSTOPERATIVE PERIOD, ELECTRODES WERE IMMEDIATELY REMOVED, AND THE WOUND WAS CLEANED WITH CHLORHEXIDINE. IT WAS NOTED THAT ALL PATIENTS WHO EXPERIENCED LOCAL WOUND INFECTIONS WERE WITHOUT LONG-TERM SEQUELAE. 11 PATIENTS EXPERIENCED ELECTRODE MIGRATION. IT WAS NOTED THAT REGARDLESS OF OUTCOME ALL STIMULATORS WERE TURNED OFF ON POSTOPERATIVE DAY 14 AND ELECTRODES WERE EXPLANTED UNDER FLUOROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178182 EXTERNAL NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention