BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 20156465 · Received September 6, 2024

    Report

    Report Number
    3004209178-2024-18007
    Event Type
    Malfunction
    Date Received
    September 6, 2024
    Date of Event
    August 29, 2024
    Report Date
    September 6, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION D REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER MEDICAL PRODUCTS IN USE DURING THE EVENT INCLUDE: BRAND NAME INTERSTIM; PRODUCT ID 3093-28 (LOT: V250970); PRODUCT TYPE: 0200-LEAD; IMPLANT DATE (B)(6) 2009.; 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 AN HEALTHCARE PROVIDER VIA A MANUFACTURING REPRESENTATIVE REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY/BOWEL DYSFUNCTION/SACRAL NERVE STIM AND URGE INCONTINENCE. IT WAS REPORTED THAT DURING THE PATIENT'S DEVICE REPLACEMENT SURGERY THEY ATTEMPTED TO REMOVE THE ENTIRE LEAD, BUT IT FRACTURED IN 2 PLACES. THE DOCTOR WAS ABLE TO REMOVE DOWN TO THE LAST 2 ELECTRODES (0 AND 1) THAT BROKE INSIDE THE ACTUAL S3 BONE SEAM. THEY TRIED TO GET OUT AS MUCH AS POSSIBLE. THE CAUSE WAS UNKNOWN. LESS THAN 6CM WERE LEFT BEHIND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139472 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female SEE H11...