BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2052523 · Received April 11, 2011

    Report

    Report Number
    3004209178-2011-02728
    Event Type
    Injury
    Date Received
    April 11, 2011
    Date of Event
    January 1, 2011
    Report Date
    April 1, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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 PT HAD THEIR NEUROSTIMULATOR SYS EXPLANTED DUE TO INFECTION. ADDITIONAL INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 7427V NA

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V558073| EXTENSION: MODEL 7489, LOT# NHU222400V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU222399V| LEAD: MODEL 3093, LOT# V558073| IMPLANTED:| EXPLANTED:| EXPLANTED: