BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2083035 · Received May 5, 2011

    Report

    Report Number
    3004209178-2011-03273
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    August 2, 2010
    Report Date
    April 15, 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
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    RECEIVED INFO THE PT EXPERIENCED A FALL AND WHICH CAUSED DISLODGEMENT OF THE LEAD REQUIRING A REVISION. THE INS AND LEAD WERE REPLACED. NO PT OUTCOME WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3058 H0235792

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention LEAD: MODEL 3889, LOT# V266139| PROGRAMMER: MODEL 3037, LOT# NJD087758N| IMPLANTED:| EXPLANTED: