BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 12641878 · Received October 15, 2021

    Report

    Report Number
    2182207-2021-01814
    Event Type
    Injury
    Date Received
    October 15, 2021
    Date of Event
    April 1, 2021
    Report Date
    October 15, 2021
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: BUCHANAN P, KIKER D, KATOUZIAN A, KIA F, POPE JE. MULTISYSTEM SPINAL CORD STIMULATION TRIALING: A SINGLE CENTER, RETROSPECTIVE, OBSERVATIONAL STUDY. PAIN PRACT. 2021.10.1111/PAPR.13016 LITERATURE SUMMARY: THE PURPOSE OF THIS STUDY WAS TO HELP DISSECT A METHODOLOGY FOR A PATIENT CENTRIC MULTISYSTEM TRIALING. THE AUTHORS ULTIMATELY CONCLUDED THAT MULTISYSTEM TRIALING WAS SAFE AND EFFECTIVE IN PROVIDING PATIENTS INCREASED EXPOSURE TO MULTIPLE COMMERCIALLY AVAILABLE SPINAL CORD STIMULATION (SCS) SYSTEMS. 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT#: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    REPORTED EVENTS: ONE PATIENT EXPERIENCED EXTREME PAIN AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND UNDERWENT DEVICE EXPLANT. ONE PATIENT UNDERWENT DEVICE EXPLANT DUE TO A LOSS OF EFFICACY. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1536560 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention