BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM X

    MDR report key: 19199241 · Received April 28, 2024

    Report

    Report Number
    3004209178-2024-09892
    Event Type
    Injury
    Date Received
    April 28, 2024
    Date of Event
    April 12, 2024
    Report Date
    April 28, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000484668
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 978B128 LOT# VA2T8PL SERIAL# IMPLANTED: (B)(6) 2024, EXPLANTED: (B)(6) 2024, PRODUCT TYPE LEAD SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 978B128, SERIAL/LOT #: (B)(6), UBD: 29-NOV-2024, UDI#: (B)(4).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

    (B)(6) 2024, MPXR 1170917 (CON): INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION (INCONTINENCE, URGENCY, AND/OR FREQUENCY). IT WAS REPORTED THAT THE PATIENT HAD A STAPH INFECTION AND THE DEVICE WAS REMOVED. A REPLACEMENT IS PLANNED FOR (B)(6) JUNE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305419 INTERSTIM X STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97800 00763000484668

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Required Intervention