BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 6400296 · Received March 13, 2017

    Report

    Report Number
    3007566237-2017-00950
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    November 26, 2016
    Report Date
    March 13, 2017
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE/DATE OF BIRTH. PLEASE NOTE THAT THIS AGE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE, AS THE ACTUAL AGE OF PATIENTS INVOLVED WAS NOT PROVIDED. SEX. PLEASE NOTE THAT THIS IS THE GENDER OF THE MAJORITY OF PATIENTS REPORTED IN THE ARTICLE AS THE ACTUAL GENDERS OF PATIENTS INVOLVED WAS NOT PROVIDED. DATE OF EVENT. PLEASE NOTE THAT THIS DATE IS BASED OFF THE DATE THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE ACTUAL EVENT DATE WAS NOT PROVIDED. THE MAIN COMPONENT OF ONE OF THE SYSTEMS INVOLVED IN THE REPORTED EVENTS; OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3898, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. 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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SLANGEN R, FABER CG, SCHAPER NC, JOOSTEN EA, VAN DONGEN RT, KESSELS AG, VAN KLEEP M, DIRKSEN CD. A TRIAL BASED ECONOMIC EVALUATION COMPARING SPINAL CORD STIMULATION WITH BEST MEDICAL TREATMENT IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY. JOURNAL OF PAIN (2017) DOI: 10.1016/J.JPAIN.2016.11.014 ABSTRACT: THE OBJECTIVE WAS TO PERFORM AN ECONOMIC EVALUATION COMPARING SPINAL CORD STIMULATION IN COMBINATION WITH BEST MEDICAL TREATMENT (SCS) WITH BEST MEDICAL TREATMENT (BMT) IN PAINFUL DIABETIC PERIPHERAL NEUROPATHY (PDPN) PATIENTS. ALONGSIDE A PROSPECTIVE TWO-CENTER RANDOMIZED CONTROLLED TRIAL, INVOLVING 36 PDPN PATIENTS WITH SEVERE LOWER LIMB PAIN, NOT RESPONDING TO CONVENTIONAL THERAPY, AN ECONOMIC EVALUATION WAS PERFORMED. INCREMENTAL COST-EFFECTIVENESS RATIOS (ICERS) WERE BASED ON SOCIETAL COSTS AND QUALITY-ADJUSTED LIFE YEARS (QALYS) AND DIRECT HEALTHCARE COSTS AND THE NUMBER OF SUCCESSFULLY TREATED PATIENTS, RESPECTIVELY, BOTH WITH A TIME HORIZON OF 12 MONTHS. BOOTSTRAP- AND SECONDARY ANALYSES WERE PERFORMED TO ADDRESS UNCERTAINTY. TOTAL SOCIETAL COST AMOUNTED TO ¿26539.18 VERSUS ¿5313.45 PER PATIENT IN THE SCS AND BMT GROUP, RESPECTIVELY. QALYS WERE 0.58 VERSUS 0.36 AND THE NUMBER OF SUCCESSFULLY TREATED PATIENTS WAS 55% VERSUS 7% FOR THE SCS AND BMT GROUP, RESPECTIVELY. THIS RESULTED IN ICERS OF ¿94159.56 PER QALY AND ¿34518.85 PER SUCCESSFULLY TREATED PATIENT, RESPECTIVELY. BOOTSTRAP ANALYSES SHOWED THAT THE PROBABILITY OF SCS BEING COST-EFFECTIVE RANGES FROM 0-46% WITH WILLINGNESS TO PAY THRESHOLD VALUES RANGING BETWEEN ¿20000 AND ¿80000 FOR QALY. SECONDARY ANALYSES SHOWED THAT COST-EFFECTIVENESS OF SCS BECAME MORE FAVORABLE AFTER CORRECTING FOR BASELINE COST IMBALANCE BETWEEN THE TWO GROUPS, EXTENDING THE DEPRECIATION PERIOD OF SCS MATERIAL TO 4 YEARS, AND EXTRAPOLATION OF THE DATA UP TO 4 YEARS. ALTHOUGH SCS WAS CONSIDERABLY MORE EFFECTIVE COMPARED TO BMT, THE SUBSTANTIAL INITIAL INVESTMENT THAT IT REQUIRED RESULTED IN SCS NOT BEING COST-EFFECTIVE AT THE SHORT-TERM. COST-EFFECTIVENESS RESULTS WERE SENSITIVE TO BASELINE COST IMBALANCES BETWEEN THE GROUPS AND THE DEPRECIATION PERIOD OF THE SCS MATERIAL. REPORTED EVENTS: ONE 1 PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR PAINFUL DIABETIC NEUROPATHY (PDNP) EXPERIENCED AN INFECTION OF THE SCS SYSTEM. ONE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR PAINFUL DIABETIC NEUROPATHY (PDNP) EXPERIENCED A COMPLICATION AND REQUIRED A LEAD REVISION. ONE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR PAINFUL DIABETIC NEUROPATHY (PDNP) EXPERIENCED A COMPLICATION AND REQUIRED A LEAD REPLACEMENT. ONE PATIENT WITH SPINAL CORD STIMULATION (SCS) FOR PAINFUL DIABETIC NEUROPATHY (PDNP) EXPERIENCED A COMPLICATION AND REQUIRED A BATTERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181768 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention