BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3123328 · Received May 21, 2013

    Report

    Report Number
    3004209178-2013-08018
    Event Type
    Injury
    Date Received
    May 21, 2013
    Report Date
    April 26, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3037 LOT# SERIAL# (B)(4), IMPLANTED: 2009 (B)(6), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID: 3093-28 LOT# V198619, IMPLANTED: 2009 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SINCE HER REVISION SEVEN MONTHS AGO, THE PATIENT WAS HAVING TROUBLE EMPTYING HER BLADDER, AND IT WAS NOTED THAT SHE COULD NOT EMPTY HER BLADDER BEFORE SURGERY. THE PATIENT GOT THE IMPLANT FOR INTERCYSTITIS AND WAS ON A DIURETIC FOR WATER. THE PATIENT HAD ALSO BEEN GETTING LAVAGE SHOTS TO EMPTY HER BLADDER AND MEDICATION WAS INSERTED TO CALM THE BLADDER DOWN. IT WAS NOTED THAT IT STARTED AGAIN LAST WEEK AND THE PATIENT HAD PROCEDURES ON MONDAY AND YESTERDAY, WHICH YIELDED 350CC AND 300CC, RESPECTIVELY. THE PATIENT WAS ON PROGRAM 1 AT 0.35 V AND SHE INCREASED IT SLIGHTLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224790 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention