BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 16835512 · Received April 28, 2023

    Report

    Report Number
    2182207-2023-00770
    Event Type
    Injury
    Date Received
    April 28, 2023
    Date of Event
    February 22, 2023
    Report Date
    April 28, 2023
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID NEU_INTERSTIM_INS, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INTERSTIM_INS , PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD , PRODUCT TYPE LEAD. SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_INTERSTIM_INS; PRODUCT ID: NEU_INTERSTIM_INS; PRODUCT ID: NEU_UNKNOWN_LEAD. 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. 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

    KUTUKOGLU, U., ALTUNTAS, T., SAHIN, B., ONUR, R. (2023). SACRAL NEUROMODULATION TREATMENT FOR URINARY VOIDING DYSFUNCTIONS: RESULTS OF TREATMENT WITH THE LARGEST SINGLE-CENTER SERIES IN A TERTIARY REFERRAL CENTER IN TURKEY. TURKISH JOURNAL OF MEDICAL SCIENCES. (2023) 53: 211-217. DOI:10.55730/1300-0144.5575 SUMMARY: BACKGROUND/AIM: SACRAL NEUROMODULATION (SNM) IS A MINIMALLY INVASIVE TREATMENT THAT MODULATES SPINAL REFLEXES TO REGULATE BLADDER, URINARY SPHINCTER, AND PELVIC FLOOR AND HAS SUCCESSFULLY BEEN USED IN THE TREATMENT OF REFRACTORY VOIDING DYSFUNCTIONS. THE AIM OF THIS STUDY WAS TO PRESENT OUR EXPERIENCE WITH SNM IN A TERTIARY REFERRAL CENTER WITH THE LARGEST NUMBER OF PATIENTS AND REVIEW THE SAFETY AND EFFICACY OF THE PROCEDURE. MATERIALS AND METHODS: A TOTAL OF 42 PATIENTS WITH REFRACTORY LOWER URINARY TRACT SYMPTOMS WERE INCLUDED INTO THE STUDY. AFTER AN INITIAL TEST PERIOD, PATIENTS WHO SHOWED MORE THAN 50% IMPROVEMENT IN THEIR SYMPTOMS UNDERWENT THE SECOND STAGE OF SNM. TWELVE PATIENTS HAD OVERACTIVE BLADDER (OAB), BLADDER PAIN SYNDROME/INTERSTITIAL CYSTITIS (BPS/IC) AND 17 HAD URINARY RETENTION. THE CLINICAL SUCCESS WAS EXAMINED DURING FOLLOW-UP BY VOIDING DIARY, URODYNAMICS, AND GLOBAL RESPONSE ASSESSMENT. RESULTS: BETWEEN FEBRUARY 2015 AND DECEMBER 2020, A TOTAL OF 29 PATIENTS UNDERWENT STAGES I & II SNM PROCEDURES. THE MEAN AGES OF PATIENTS IN OAB/BPS GROUP AND RETENTION GROUP WERE 40 (37¿57 YEARS) AND 35 (27¿44 YEARS), RESPECTIVELY. MEAN FOLLOW-UP TIME WAS AT LEAST 1 YEAR. OVERALL, 58.5% SUCCESS RATE WAS OBSERVED IN OAB, BPS/IC, AND URINARY RETENTION GROUPS. GLOBAL RESPONSE ASSESSMENT SCORE IN BOTH GROUPS INCREASED SIGNIFICANTLY (P = 0.001). NO STATISTICALLY SIGNIFICANT DIFFERENCE WAS FOUND BETWEEN SUCCESS OR FAILURE RATES WHEN SEX AND AGE WERE VARIABLE PARAMETERS (P > 0.05). CONCLUSION: SNM APPEARS TO BE AN EFFECTIVE AND SAFE TREATMENT OPTION IN RESTORING VOIDING DYSFUNCTIONS IN PATIENTS WITH REFRACTORY IDIOPATHIC AND NEUROGENIC VOIDING DYSFUNCTIONS. OUR INITIAL SERIES REVEALED FAVORABLE RESULTS; HOWEVER, FURTHER STUDIES WITH LARGER SERIES AND LONGER FOLLOW-UP ARE NEEDED. REPORTED EVENTS: 1. FIVE PATIENTS HAD REVISION OF THE PLACE OF ELECTRODE WHO HAD LOSS OF THERAPEUTIC EFFICACY. HOWEVER, NEITHER NEW LEAD PLACEMENT NOR PLACING THE ELECTRODE TO CONTRALATERAL S3 FORAMEN YIELDED SUCCESSFUL RESULTS. THUS, THEY DISCONTINUED THE REVISION OF ELECTRODE DUE TO NO ADDITIONAL BENEFIT. 2. THREE PATIENTS HAD PAIN ON IMPLANT SITE AND IPG WAS MOVED TO ANOTHER PART IN THESE PATIENTS. 3. ONE PATIENT HAD AN INFECTION IN WHOM ALL SYSTEM WAS REMOVED. 4. ONE PATIENT EXPERIENCED LEAD MIGRATION AND REQUIRED REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275256 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_INTERSTIM_INS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention SEE H10.