BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 10781095 · Received November 3, 2020

    Report

    Report Number
    2182207-2020-01203
    Event Type
    Injury
    Date Received
    November 3, 2020
    Date of Event
    May 6, 2020
    Report Date
    November 3, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: POULSEN DM, SORENSEN JCH, BLICHFELDT-ECKHARDT MR, ET AL. PAIN CATASTROPHIZING DOES NOT PREDICT SPINAL CORD STIMULATION OUTCOMES: A COHORT STUDY OF 259 PATIENTS WITH LONG-TERM FOLLOW-UP. NEUROMODULATION. 2020. 10.1111/NER.13213. 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 SPECIFIC EVENT DATES WERE 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. PLEASE NOTE THE DEVICES INVOLVED IN THE ARTICLE WERE NOTED TO HAVE BEEN MANUFACTURED BY MEDTRONIC, ABBOTT, AND BOSTON SCIENTIFIC; SPECIFIC DEVICE IDENTITIES ARE UNKNOWN AT THIS TIME. FOLLOW-UP HAS BEEN REQUESTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    LITERATURE SUMMARY: SPINAL CORD STIMULATION (SCS) IS AN IMPORTANT TREATMENT MODALITY USED TO TREAT CHRONIC NEUROPATHIC PAIN. HOWEVER, REPORTED SUCCESS RATES OF 26%-70% ENTAIL AN INCREASED FOCUS ON PATIENT SELECTION. AN AREA OF CORE INTEREST IS PSYCHOLOGICAL EVALUATION, OFTEN USING SCALES SUCH AS THE PAIN CATASTROPHIZING SCALE (PCS). THE AIM OF THIS STUDY WAS TO ASSESS THE RELATION BETWEEN BASELINE PCS SCORES OBTAINED BEFORE IMPLANTATION AND SCS OUTCOMES DEFINED AS RATING ON PATIENTS¿ GLOBAL IMPRESSION OF CHANGE SCALE (PGIC), PAIN RELIEF ON THE NUMERIC RATING SCALE (NRS), CESSATION OF PAIN MEDICATION, AND RISK OF PERMANENT EXPLANTATION. THE AUTHORS ULTIMATELY CONCLUDED THAT THE STUDY DID NOT DEMONSTRATE ANY ASSOCIATIONS BETWEEN BASELINE PCS SCORES AND SCS OUTCOMES. REPORTED EVENTS: 31 PATIENTS UNDERWENT PERMANENT EXPLANTATION OF THEIR SPINAL CORD STIMULATION (SCS) SYSTEM DURING THE FOLLOW-UP PERIOD. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1245106 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention