BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1994285 · Received January 14, 2011

    Report

    Report Number
    3004209178-2011-00379
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 1, 2010
    Report Date
    January 10, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION IN THEIR BLADDER, AND A LOSS OF THERAPEUTIC EFFECT. THIS OCCURRED AFTER HAVING A PROCEDURE INVOLVING A HEART MONITOR IN (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT TRIED ALL FOUR PROGRAMS AND EACH ONE ONLY WORKED FOR A SHORT TIME BEFORE IT LOST THERAPEUTIC EFFECT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 70 YR PROGRAMMER: MODEL 3037, LOT# NJD093809N| LEAD: MODEL 3093, LOT# V380838| EXPLANTED:| IMPLANTED: