BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 23096026 · Received September 19, 2025

    Report

    Report Number
    3004209178-2025-15909
    Event Type
    Injury
    Date Received
    September 19, 2025
    Report Date
    September 19, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B#: EVENT DATE IS UNKNOWN. SEE B5 FOR CONTEXT IF APPLICABLE. SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME SURESCAN; PRODUCT ID 978B128 (LOT: VA2MFKB); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2022; EXPLANT DATE (B)(6) 2024 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

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DISFUNCTION AND URGE INCONTINENCE. IT WAS REPORTED THAT THE PATIENT HAD A LEAD REVISION ON 08/222/2024 AND SURGICAL NOTES REPORTED THAT OLD LEAD WAS REPLACED WITH NEW LEAD. THE REASON FOR REPLACEMENT WAS UNKNOWN BY CALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1397885 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H11...