BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2576928 · Received May 16, 2012

    Report

    Report Number
    3004209178-2012-03370
    Event Type
    Injury
    Date Received
    May 16, 2012
    Report Date
    April 18, 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
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28 LOT# V151684 SERIAL# IMPLANTED: 2008-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3037 LOT# (B)(4) IMPLANTED: 2008-(B)(6) EXPLANTED: PRODUCT TYP PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT LOST THERAPEUTIC RELIEF FROM THEIR DEVICE APPROXIMATELY ONE MONTH PRIOR TO REPORT. IT WAS ALSO STATED THE PATIENT WAS TREATED FOR A URINARY TRACT INFECTION ON (B)(6) 2012. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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