BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTERSTIM II

    MDR report key: 2223821 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06546
    Event Type
    Other
    Date Received
    August 18, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 28, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED AFTER ITS USE BEFORE DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR LEAD: MODEL 3093, LOT# V772513| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD091620N| IMPLANTED: