BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3070903 · Received April 22, 2013

    Report

    Report Number
    3004209178-2013-06645
    Event Type
    Injury
    Date Received
    April 22, 2013
    Report Date
    April 2, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3889-28 LOT# V535687, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT HAD A URINARY TRACT INFECTION. IT WAS STATED, THE PATIENT HAD TO TURN OFF THE IMPLANTABLE NEUROSTIMULATOR (INS) SO THEY COULD VOID, AS THEY COULD NOT VOID WHEN THE INS WAS ON. IT WAS NOTED THAT THE IMPLANT WAS WORKING "GREAT" AND WAS HELPING THE PATIENT'S SYMPTOMS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172160 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention