BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 17632945 · Received August 28, 2023

    Report

    Report Number
    2182207-2023-01730
    Event Type
    Injury
    Date Received
    August 28, 2023
    Date of Event
    July 13, 2023
    Report Date
    August 28, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_INTERSTIM_INS LOT# UNKNOWN. PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN PRODUCT ID NEU_INTERSTIM_INS LOT# UNKNOWN. PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INTERSTIM_INS, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN BRUSCIANO, L., BRILLANTINO, A., PELLINO, G., MARINELLO, F., ET AL. (2023). SACRAL NERVE MODULATION FOR PATIENTS WITH FECAL INCONTINENCE: LONG-TERM OUTCOME AND EFECTS ON SEXUAL FUNCTION. UPDATES IN SURGERY (2023) 75:1187¿1195. HTTPS://DOI.ORG/10.1007/S13304-023-01570-Z A.3. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. B.3. PLEASE NOTE THAT THIS DATE IS BASED OFF OF THE DATE OF PUBLICATION OF THE ARTICLE [OR THE DATE THAT THE ARTICLE WAS ACCEPTED FOR PUBLICATION] AS THE EVENT DATES WERE NOT PROVIDED IN THE PUBLISHED LITERATURE. B.5. 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 G.2. COUNTRY: ITALY 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Description of Event or Problem · 0

    SUMMARY: SACRAL NERVE MODULATION HAS BECOME AN ESTABLISHED TREATMENT FOR FECAL AND URINARY INCONTINENCE, AND SEXUAL DISORDERS. THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE LONG-TERM OUTCOME OF SACRAL NEUROMODULATION IN PATIENTS WITH FECAL OR COMBINED FECAL AND URINARY INCONTINENCE (DOUBLE INCONTINENCE), ASSESSING ITS SAFETY, EFFICACY, AND IMPACT ON QUALITY OF LIFE AND SEXUAL FUNCTION. THIS WAS A MULTICENTRIC, RETROSPECTIVE, COHORT STUDY INCLUDING PATIENTS WITH FECAL OR DOUBLE INCONTINENCE WHO RECEIVED SACRAL NEUROMODULATION AT SEVEN EUROPEAN CENTERS BETWEEN 2007 AND 2017 AND COMPLETED A 5-YEAR FOLLOW-UP. THE MAIN OUTCOME MEASURES INCLUDED IMPROVEMENTS OF INCONTINENCE SYMPTOMS AND QUALITY OF LIFE COMPARED WITH BASE[1]LINE, EVALUATED USING VALIDATED TOOLS AND QUESTIONNAIRES AT 1-, 6-, 12-, 36- AND 60-MONTH FOLLOW-UP. 108 (102 WOMEN, MEAN AGE 62.4±13.4 YEARS) PATIENTS WERE RECRUITED, OF WHOM 88 (81.4%) UNDERWENT DEFINITIVE IMPLANTATION OF THE PACEMAKER. PATIENTS¿ BASELINE MEDIAN CLEVELAND CLINIC INCONTINENCE SCORE WAS 15 (10¿18); IT DECREASED TO 2 (1¿4) AND 1 (1¿2) AT THE 12- AND 36- MONTH FOLLOW-UP (P<(><<)>0.0001), REMAINING STABLE AT THE 5-YEAR FOLLOW UP. FECAL INCONTINENCE QUALITY OF LIFE SCORE IMPROVED SIGNIFICANTLY. ALL PATIENT WITH SEXUAL DYSFUNCTION (N=48) AT BASELINE REPORTED SYMPTOM RESOLUTION AT THE 5-YEAR FOLLOW UP. THE STUDY WAS LIMITED BY THE RETROSPECTIVE DESIGN AND THE RELATIVELY SMALL PATIENT SAMPLE. SACRAL NERVE MODULATION IS AN EFFECTIVE TREATMENT FOR FECAL AND DOUBLE INCONTINENCE, ACHIEVING SATISFACTORY LONG-TERM SUCCESS RATE, WITH RESOLUTION OF CONCOMITANT SEXUAL DYSFUNCTION.   REPORTED EVENTS: 1.       THREE PATIENTS HAD INFECTION AT IMPLANTING SITE AND WAS DEVICE WAS REMOVED. 2.       FIVE PATIENTS HAD PAIN THAT WAS NOT RESOLVED SO THE DEVICE WAS PERMANENTLY REMOVED. 3.       FOUR PATIENTS HAD PAIN AT THE IMPLANT SITE AND WAS REVISED; THE DEVICE WAS REMOVED AND REIMPLANTED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328888 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention "SEE H10...."