BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3013192 · Received March 20, 2013

    Report

    Report Number
    3004209178-2013-03980
    Event Type
    Injury
    Date Received
    March 20, 2013
    Report Date
    March 4, 2013
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# VA00SW8, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE MONTH AFTER THE PATIENT WAS IMPLANTED IN (B)(6) 2012; IT HAD "STOPPED WORKING". IT WAS NOTED THAT THE TRIAL IN (B)(6) 2012 "WENT WELL". IT WAS STATED THAT THE DOCTOR THOUGHT THAT THE BATTERY MAY BE DEFECTIVE AND HAD ORDERED A REVISION SURGERY AND THE DOCTOR THOUGHT IT WAS THE LEAD. IT WAS REPORTED THAT 2 WEEKS AFTER THAT THE HCP SCHEDULED ANOTHER SURGERY AND CHANGED THE LEAD. ADDITIONAL INFORMATION WAS REQUESTED AND IF RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116848 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention