BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR FOR SCS

    MDR report key: 7357637 · Received March 21, 2018

    Report

    Report Number
    3007566237-2018-00849
    Event Type
    Injury
    Date Received
    March 21, 2018
    Date of Event
    May 1, 2017
    Report Date
    March 21, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: AIUDI CM, DUNN RY, BURNS SM, ROTH SA, OPALACZ A, ZHANG Y, CHEN L, MAO J, AHMED SU. LOSS OF EFFICACY TO SPINAL CORD STIMULATOR THERAPY: CLINICAL EVIDENCE AND POSSIBLE CAUSES. PAIN PHYSICIAN. 2017; PLEASE NOTE THIS DATE IS BASED OFF OF THE ARTICLE¿S "ACCEPTED FOR PUBLICATION" DATE AS THE 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. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ABSTRACT: THE PURPOSE OF THIS STUDY WAS TO INVESTIGATE WHETHER A LOSS OF EFFICACY (LOE) PHENOMENON EXISTS WITH SPINAL CORD STIMULATION (SCS) THERAPY AND TO INVESTIGATE IF THIS PHENOMENON IS MORE APPARENT IN ANY SPECIFIC PATIENT POPULATION. THE AUTHORS CONCLUDED THAT PATIENTS WHO RECEIVED SCS HAD A SIGNIFICANT INCREASE IN VISUAL ANALOG SCALE (VAS) SCORES OVER TIME AND THAT THEIR DATA DID NOT SHOW ANY BASELINE PATIENT CHARACTERISTIC THAT HELPED PREDICT LOE. HOWEVER, PATIENTS WHO HAVE SIGNIFICANT BASELINE RESPONSE TO THERAPY MAY BE MORE LIKELY TO EXPERIENCE LOE. REPORTED EVENTS: THREE PATIENTS HAD THEIR SPINAL CORD STIMULATOR REMOVED PRIOR TO THEIR ONE-MONTH POST-IMPLANT FOLLOW-UP. NO FURTHER EVENT INFORMATION WAS REPORTED REGARDING THESE PATIENTS. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200309 IMPLANTABLE NEUROSTIMULATOR FOR SCS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention