BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 1950086 · Received December 7, 2010

    Report

    Report Number
    3004209178-2010-10259
    Event Type
    Malfunction
    Date Received
    December 7, 2010
    Date of Event
    October 1, 2010
    Report Date
    November 30, 2010
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NEVER HAD THERAPEUTIC EFFECT FOLLOWING THE IMPLANT OF THE NEUROSTIMULATOR. X-RAYS TAKEN CONFIRMED THAT THE LEAD HAD MIGRATED. THERE WAS NO ACCIDENT OR INCIDENT RELATED TO THIS EVENT. THE PT MET WITH THE COMPANY REP LAST WEEK AND WAS REPROGRAMMED. SHE NOW FELT THE STIMULATION.

    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 69 YR PROGRAMMER: MODEL 3037, LOT# NJD103231N| EXPLANTED:| LEAD: MODEL 3093, LOT# V540740| IMPLANTED: