BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 9383270 · Received November 27, 2019

    Report

    Report Number
    3004209178-2019-22736
    Event Type
    Injury
    Date Received
    November 27, 2019
    Report Date
    December 20, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994287724
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28, LOT# V223166, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD, UDI: (B)(4), UBD: 2013-03-06. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION. IT WAS REPORTED THAT THE PATIENT¿S INS WAS REPLACED BECAUSE IT HADN¿T BEEN WORKING FOR YEARS. THE CALLER ELABORATED THAT IF DIDN¿T WORK FOR 5 YEARS. NO PATIENT SYMPTOMS WERE REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) IN RESPONSE TO AN INQUIRY FOR MORE DETAILS REGARDING THE EVENT: PATIENT WEIGHT WAS (B)(6) ON (B)(6) 2019. THE CAUSE OF THE 2009 DEVICE NOT WORKING WAS LEAD MIGRATION. THE DEVICE IS STILL IN PLACE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1179840 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994287724

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention