BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 8213475 · Received January 3, 2019

    Report

    Report Number
    3007566237-2019-00019
    Event Type
    Injury
    Date Received
    January 3, 2019
    Date of Event
    May 30, 2018
    Report Date
    October 20, 2020
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D11: PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID NEU_INS_STIMULATOR LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. 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

    PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_INS_STIMULATOR, LOT #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT #: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, LOT #: UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_INS_STIMULATOR, LOT #: UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_INS_STIMULATOR, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED. (B)(6).

    Description of Event or Problem · 1

    LE FOULER, A., DUCHALAIS, E., LOONG, T. H., BAAYEN, C., WYART, V., KUBIS, C., MEURETTE, G., LEHUR, P. A. LONG-TERM OUTCOME FOLLOWING IMPLANTED PULSE GENERATOR CHANGE IN PATIENTS TREATED WITH SACRAL NERVE MODULATION FOR FECAL INCONTINENCE. NEUROMODULATION. 2018. 21(7): 694-699. DOI: 10.1111/NER.12806. SUMMARY: LONG-TERM OUTCOME OF SACRAL NERVE MODULATION (SNM) PATIENTS AFTER IMPLANTED PULSE GENERATOR (IPG) CHANGE FOR FECAL INCONTINENCE (FI) IS UNKNOWN. THIS STUDY REPORTED THE OUTCOME AND LONG-TERM SATISFACTION AFTER A CHANGE OF AN EXHAUSTED IPG, QUESTIONING THE NEED TO CONCURRENTLY CHANGE THE ELECTRODE AND LOOKING FOR FACTORS INVOLVED IN THE MAINTENANCE OF TREATMENT EFFICIENCY. PATIENTS WITH FECAL INCONTINENCE AND WITH A MEDTRONIC IPG IMPLANTED IN A SINGLE CENTER (2001¿2016) WERE PROSPECTIVELY FOLLOWED UP. SATISFACTION WAS GRADED ACCORDING TO A PATIENT-REPORTED OUTCOME MEASURE FROM 0 TO 10. A PRE- AND POSTREPLACEMENT FI SEVERITY SCORE (CLEVELAND CLINIC FECAL INCONTINENCE SCORE) AND FECAL INCONTINENCE QUALITY OF LIFE QUESTIONNAIRE WERE ALSO COLLECTED. IN 170 PATIENTS WITH SNM, 39 HAD AN IPG REPLACEMENT. AT A MEDIAN OF 29 MONTH AFTER REPLACEMENT, 32 AND 7 PATIENTS REPORTED RESPECTIVELY A SIMILAR AND REDUCED SATISFACTION (7.6, 1.62 VS. 5.5, 0.87), P .001. SATISFIED PATIENTS WERE YOUNGER (65 YEARS VS. 76 YEARS, P .001). CLEVELAND CLINIC FECAL INCONTINENCE SCORES WERE NOT SIGNIFICANTLY DIFFERENT, BUT THE SATISFIED GROUP HAD A SIGNIFICANTLY BETTER FECAL INCONTINENCE QUALITY OF LIFE SCORE (P = .047). ONLY 5 PATIENTS NEEDED AN ELECTRODE CHANGE AT THE TIME OF THE IPG REPLACEMENT OR LATER. PATIENT SATISFACTION AND EFFICIENCY REMAIN HIGH AFTER IPG REPLACEMENT. OLDER AGE HAS A NEGATIVE IMPACT ON THE OUTCOME. ELECTRODE REPLACEMENT IS RARELY REQUIRED AND DOES NOT NEED TO BE PERFORMED ROUTINELY WHEN AN IPG IS EXHAUSTED. REPORTED EVENTS: OF THE 170 FI PATIENTS IMPLANTED WITH A PERMANENT SNM, 28 WERE EXCLUDED (DEFINITIVELY EXPLANTED OR IPG TURNED OFF FOR VARIOUS REASONS: PATIENT REQUEST, TREATMENT INEFFICIENCY, CONCURRENT MEDICAL CONDITION). THE STUDY GROUP WAS COMPOSED OF 39 PATIENTS(25 INTERSTIM AND 14 INTERSTIM II) THAT HAVE HAD AN IPG REPLACEMENT BECAUSE 6 PATIENTS DECIDED TO STOP SNM (LACK OR LOSS OF EFFICIENCY, PATIENT¿S WISH). TWO PATIENTS NOT INCLUDED IN THE SERIES REQUIRED A SIMULTANEOUS REPLACEMENT OF THE STIMULATING ELECTRODE AS A HIGH IMPEDANCE ON THE 4 STIMULATING PLOTS WERE IDENTIFIED BEFORE IPG EXHAUSTION. THE STUDY GROUP INCLUDED 33 PATIENTS WITH A REPLACED IPG FUNCTIONING WITH THE INITIAL ELECTRODE, 3 THAT HAVE HAD AN ELECTRODE REPLACEMENT DURING THE COURSE OF THE STUDY BECAUSE OF POOR RESULTS WITH THE NEWLY IMPLANTED IPG AND 1 EXPLANTED BECAUSE OF POOR SNM RESULTS AFTER BATTERY CHANGE. NO SPECIFIC DEVICE INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7039 IMPLANTABLE NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention