BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3816140 · Received May 16, 2014

    Report

    Report Number
    3004209178-2014-09141
    Event Type
    Injury
    Date Received
    May 16, 2014
    Date of Event
    February 25, 2014
    Report Date
    October 16, 2024
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-33, LOT# V895691, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD; PRODUCT ID 3889-33, LOT# V895691, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STIMULATOR WAS UNRESPONSIVE. INTERVENTION INVOLVED A LEAD REVISION. ADDITIONAL INFORMATION REPORTED THE LEAD WAS EXPLANTED AND REPLACED. THE EVENT RESOLVED WITHOUT SEQUELAE. ADDITIONAL INFORMATION REPORTED THE LEAD WAS FRACTURED. IT WAS ALSO NOTED THE PATIENT HAD URGE INCONTINENCE. ADDITIONAL INFORMATION NOTED IT WAS A RIGHT SIDED FRACTURE OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294737 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCON EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Required Intervention "SEE H10....".| "SEE H11....".