BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 16645851 · Received March 30, 2023

    Report

    Report Number
    2182207-2023-00581
    Event Type
    Injury
    Date Received
    March 30, 2023
    Date of Event
    December 3, 2022
    Report Date
    March 30, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: ZUIDEMA X, VAN DAAL E, VAN GEEL I, DE GEUS TJ, VAN KUIJK SMJ, DE GALAN BE, DE MEIJ N, VAN ZUNDERT J. LONG-TERM EVALUATION OF SPINAL CORD STIMULATION IN PATIENTS WITH PAINFUL DIABETIC POLYNEUROPATHY: AN EIGHT-TO-TEN-YEAR PROSPECTIVE COHORT STUDY. NEUROMODULATION. 2022 DEC 30:S1094-7159(22)01403-9. DOI: 10.1016/J.NEUROM.2022.12.003 A2: THIS VALUE IS THE AVERAGE AGE 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 ACCEPTANCE DATE AS SPECIFIC EVENT DATES WERE 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 NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# SERIAL# UNKNOWN IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, 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

    LITERATURE SUMMARY: THIS STUDY AIMED TO EVALUATE THE LONG-TERM EFFECTS OF SPINAL CORD STIMULATION (SCS) IN PATIENTS WITH PAINFUL DIABETIC POLYNEUROPATHY (PDPN). THIS PROSPECTIVE COHORT STUDY WAS THE EIGHT-TO-TEN¿YEAR FOLLOW-UP OF A PREVIOUSLY PERFORMED PILOT AND R ANDOMIZED CONTROLLED TRIAL ON THE EFFECTS OF SCS IN PDPN, INITIATED BY THE MULTIDISCIPLINARY PAIN CENTER OF MAASTRICHT UNIVERSITY MEDICAL CENTER+. THE STUDY POPULATION CONSISTED OF A SUBGROUP OF PATIENTS WHO STILL USED SCS TREATMENT = EIGHT YEARS AFTER IMPLANTATION (N = 19). PAIN INTENSITY SCORES (NUMERIC RATING SCALE [NRS]) DURING THE DAY AND NIGHT AND DATA ON SECONDARY OUTCOMES (IE, QUALITY OF LIFE, DEPRESSION, SLEEP QUALITY) WERE REPORTED DURING YEARLY FOLLOW-UP CONSULTATIONS. LONG-TERM EFFICACY OF SCS WAS ANALYZED BY COMPARING THE MOST RECENTLY OBTAINED DATA EIGHT TO TEN YEARS AFTER IMPLANTATION WITH THOSE OBTAINED AT BASELINE. PAIN INTENSITY, DAY AND NIGHT, WAS SIGNIFICANTLY (P <(><<)> 0.01) REDUCED BY 2.3 (NRS 6.6¿4.3) AND 2.2 (NRS 6.8¿4.6) POINTS, RESPECTIVELY, WHEN COMPARING THE LONG-TERM DATA WITH BASELINE. MOREOVER, FOR > 50% OF PATIENTS, THE PAIN REDUCTION WAS > 30%, WHICH IS CONSIDERED CLINICALLY MEANINGFUL. NO DIFFERENCES WERE FOUND REGARDING THE SECONDARY OUTCOMES. THIS EIGHT-TO-TEN¿YEAR FOLLOW-UP STUDY INDICATES THAT SCS CAN REMAIN AN EFFECTIVE TREATMENT IN THE LONG TERM TO REDUCE PAIN INTENSITY IN A SUBCOHORT OF PATIENTS WITH PDPN WHO STILL HAD AN SCS DEVICE IMPLANTED AFTER EIGHT YEARS. REPORTED EVENTS: 1. 1 PATIENT'S IMPLANT WAS REMOVED BECAUSE OF AN ALLERGIC REACTION TO NICKEL. 2. 10 PATIENTS' IMPLANTS WERE REMOVED DUE TO LOSS OF TREATMENT EFFECT; THIS WAS MAINLY OBSERVED OVER TWO TO THREE YEARS. 3. 2 PATIENTS' IMPLANTS WERE EXPLANTED DUE TO TREATMENT COMPLICATION DURING THE FIRST YEAR OF IMPLANTATION, REFLECTED BY INFECTIONS CAUSED BY THE IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242767 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Unknown Required Intervention