BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTERNAL NEUROSTIMULATOR

    MDR report key: 25007525 · Received April 27, 2026

    Report

    Report Number
    2182207-2026-01108
    Event Type
    Malfunction
    Date Received
    April 27, 2026
    Date of Event
    August 13, 2025
    Report Date
    May 27, 2026
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LAGUNAS, A.C., CHEN, P., RUIZ, R., JHAND, A.S., BAISHYA, N., LEMPKA, S.F., ET AL. (2025). FACTORS AFFECTING ANAL SPHINCTER RECRUITMENT DURING INTRAOPERATIVE PUDENDAL NERVE STIMULATION: AN OBSERVATIONAL STUDY. INTERNATIONAL UROGYNECOLOGY JOURNAL. (2025) 37:175¿182. HTTPS://DOI.ORG/10.1007/S00192-025-06238 CONTINUATION OF D10: PRODUCT ID NEU_UNKNOWN_LEAD LOT# UNKNOWN SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN A2: PLEASE NOTE THE AGE PROVIDED IS THE MEDIAN AGE OF THE STUDY COHORT, AS MORE SPECIFIC DATA WAS NOT AVAILABLE. A3: PLEASE NOTE THE SEX PROVIDED IS THE MAJORITY SEX OF THE STUDY COHORT, AS MORE SPECIFIC DATA WAS NOT AVAILABLE. 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 SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    REPORTED EVENTS:  1. 11 FEMALE PATIENTS HAD LEAD MIGRATION. SIX HAD LEAD MIGRATION GREATER THAN 5 MM, AND 5 HAD LEAD MIGRATION LESS THAN 5MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303118 EXTERNAL NEUROSTIMULATOR STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC NEUROMODULATION NEU_ENS_STIMULATOR UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1