BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12589724 · Received October 7, 2021

    Report

    Report Number
    2182207-2021-01743
    Event Type
    Injury
    Date Received
    October 7, 2021
    Date of Event
    April 6, 2021
    Report Date
    October 7, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: CORDERO TOUS N, SANCHEZ CORRAL C, ORTIZ GARCIA IM, JOVER VIDAL A, GALVEZ MATEOS R, OLIVARES GRANADOS G. HIGH-FREQUENCY SPINAL CORD STIMULATION AS RESCUE THERAPY FOR CHRONIC PAIN PATIENTS WITH FAILURE OF CONVENTIONAL SPINAL CORD STIMULATION. EUR J PAIN. 2021.10.1002/EJP.1776. AGE OR DATE OF BIRTH: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX: THIS VALUE REFLECTS THE SEX OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. DATE OF EVENT: PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S ACCEPTANCE DATE AS THE SPECIFIC EVENT DATE WAS NOT PROVIDED IN THE PUBLISHED LITERATURE. 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. DEVICE AVAILABLE FOR EVALUATION: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN. PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU; PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN, UBD: ASKU, UDI#: ASKU. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: THIS STUDY AIMED TO EVALUATE THE EFFICACY OF 10-KHZ HIGH-FREQUENCY (HF10) DEVICES AS A RESCUE TREATMENT IN PATIENTS WITH FAILURE OF CONVENTIONAL SPINALCORD STIMULATION (SCS) THERAPY FOR CHRONIC PAIN WITHOUT THE NEED TO CHANGE THE SPINAL HARDWARE. THE AUTHORS CONCLUDED THAT THEIR RESULTS SUGGESTED THAT ANALGESIC RESCUE WITH HF10-SCS WAS AN EFFECTIVE THERAPEUTIC OPTION FOR NON-RESPONDERS TO CONVENTIONAL SCS, ALTHOUGH OBESITY MIGHT BE A LIMITING FACTOR FOR TREATMENT SUCCESS. REPORTED EVENTS: IT WAS REPORTED THAT FIVE OF SIX PATIENTS WHOSE DEVICES CEASED TO BE EFFECTIVE AFTER AT LEAST TWO YEARS OF ADEQUATE FUNCTIONING WERE IMPLANTED WITH A CONVENTIONAL LOW-FREQUENCY SPINAL CORD STIMULATION (SCS) SYSTEM THAT WAS MANUFACTURED BY THE REPORTING MANUFACTURER. IT WAS NOTED THAT THESE SIX PATIENTS CARRIED THE TONIC LOW-FREQUENCY SCS SYSTEM FOR AT LEAST 2 YEARS WITH OPTIMAL FUNCTIONING (IMPROVEMENT OF PREVIOUS CONDITION BY 50% OR MORE) AND REFERRED AT LEAST ONE OF THE FOLLOWING ISSUES DURING FOLLOW-UP: DECREASE IN PAIN IMPROVEMENT BELOW 50% (FOUR PATIENTS), DEVELOPMENT OF VERY UNCOMFORTABLE PARAESTHESIA (ONE PATIENT) AND CHANGE IN THE COVERAGE AREA OF PAIN THAT COULD NOT BE REMEDIED BY REPROGRAMMING (ONE PATIENT). IT WAS UNKNOWN WHICH FIVE OF THESE SIX PATIENTS WERE IMPLANTED WITH DEVICES MANUFACTURED BY THE REPORTING MANUFACTURER. THESE PATIENTS EXISTING LEADS WERE THEN CONNECTED TO A HIGH-FREQUENCY EXTERNAL NEUROSTIMULATOR (ENS) THROUGH ANOTHER MANUFACTURER¿S ADAPTER AND WERE FOUND TO IMPROVE TO THE PREVIOUS CONDITION OF 50% OR MORE IMPROVEMENT. THE PATIENTS WERE THEN IMPLANTED WITH A NEW, HIGH FREQUENCY IMPLANTABLE NEUROSTIMULATOR (INS) AND POCKET ADAPTER, WITHOUT REMOVING OR MODIFYING THE EPIDURAL LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1489314 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention