BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 4048817 · Received August 29, 2014

    Report

    Report Number
    3007566237-2014-02434
    Event Type
    Injury
    Date Received
    August 29, 2014
    Report Date
    October 7, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE: 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 GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED 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_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE EQUIPMENT HAD BEEN REMOVED PRIOR TO THE TREATMENT DISCUSSED IN THE ARTICLE.

    Description of Event or Problem · 1

    MONSIVAIS, J.J., MONSIVAIS, D.B. THE LONG-TERM SAFETY AND EFFICACY OF INTRATHECAL THERAPY USING SUFENTANIL IN CHRONIC INTRACTABLE NO N-MALIGNANT PAIN. THE KOREAN JOURNAL OF PAIN. 2014;27(3):297-300. DOI: 10.3344/KJP.2014.27.3.297. SUMMARY: THIS REPORT DESCRIBES THE LONG TERM SAFETY AND EFFICACY OF INTRATHECAL THERAPY USING SUFENTANIL FOR THE MANAGEMENT OF CHRONIC INTRACTABLE NEUROPATHIC PAIN IN 12 CHRONIC PAIN PATIENTS. STANDARDIZED PSYCHOLOGICAL SCREENING WAS USED TO DETERMINE TREATMENT SUITABILITY. EVALUATION DATA INCLUDED THE VISUAL ANALOG SCALE (VAS), WONG-BAKER FACES SCALE, BRIEF PAIN INVENTORY (BPI), DISABILITY OF ARM, SHOULDER, AND HAND (DASH), MCGILL QUALITY OF LIFE QUESTIONNAIRE, AND COMPLICATIONS (GRANULOMAS, TOXICITY, WITHDRAWAL, OR DEATHS). SPSS VERSION 18 WAS USED FOR DATA ANALYSIS. PRE- AND POST- TREATMENT BPI MEASURES AND PAIN SCALE SCORES SHOWED A STATISTICALLY SIGNIFICANT DIFFERENCE. THERE WERE NO COMPLICATIONS DIRECTLY RELATED TO DRUG TOXICITY, NOR DRUG WITHDRAWALS, GRANULOMAS, OR DEATHS. INTRATHECAL THERAPY WITH SUFENTANIL THERAPY OFFERS A GOOD TREATMENT ALTERNATIVE FOR THOSE CASES THAT HAVE FAILED BOTH SURGERY AND STANDARD PAIN TREATMENT. STRICT PATIENT SELECTION BASED ON PSYCHOLOGICAL SCREENING, CONTROL OF CO-MORBIDITIES, A PROPER PAIN MANAGEMENT MAY CONTRIBUTE TO SUCCESSFUL OUTCOME. REPORTED EVENTS: FOUR PATIENTS HAD FAILED SPINAL CORD STIMULATORS. THE SOURCE LITERATURE DID NOT INCLUDE ANY SPECIFIC DEVICE INFORMATION. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    530369 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 00053 YR Required Intervention