BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2800414 · Received October 22, 2012

    Report

    Report Number
    3004209178-2012-09419
    Event Type
    Injury
    Date Received
    October 22, 2012
    Report Date
    October 1, 2012
    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
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-33, LOT# V701764, IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS IN THE HOSPITAL THE WEEK PRIOR TO THIS REPORT TO HAVE HER GALLBLADDER REMOVED AND SHE HAD TO BE CATHETERIZED IN ORDER TO EMPTY HER BLADDER. THE PATIENT WENT HOME AND WAS STILL HAVING PROBLEM EMPTYING. THE PATIENT TURNED HER STIMULATION UP TO 3 AND WAS IN PAIN AND SCREAMING. THE PATIENT AND HER HUSBAND WERE ABLE TO TURN THE STIMULATION DOWN. THE PATIENT WAS GOING TO TURN UP HER STIMULATION TO A COMFORTABLE LEVEL AND MONITOR HER SYMPTOMS FOR 3-5 DAYS. 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
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention