BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2474163 · Received March 1, 2012

    Report

    Report Number
    3004209178-2012-01286
    Event Type
    Injury
    Date Received
    March 1, 2012
    Report Date
    February 1, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28, LOT V223177, IMPLANTED (B)(6) 2009, EXPLANTED: (B)(6) 2009. LEAD MODEL 3889-28, LOT V223177, IMPLANTED (B)(6) 2009, EXPLANTED: (B)(6) 2009. PROGRAMMER MODEL 3037, SERIAL (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS REMOVED ON AN UNKNOWN DATE IN (B)(4) 2009 DUE TO INFECTION. NO ADDITIONAL INFORMATION WAS PROVIDED. IF ADDITIONAL INFORMATION IS OBTAINED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention