BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2162007 · Received July 11, 2011

    Report

    Report Number
    3004209178-2011-05304
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    May 2, 2011
    Report Date
    June 16, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT'S SURGICAL SITE WAS TENDER WITH PUS DRAINAGE. THE HEALTH CARE PROFESSIONAL EXAMINED IT AND THE INCISION HAD A FOUL SMELL. THE SURROUNDING TISSUE WAS ERYTHEMATOUS AND TENDER. THE PATIENT HAD DEVELOPED CELLULITIS IN HER BUTTOCKS. THE NEUROSTIMULATOR AND LEAD WERE EXPLANTED. THE PATIENT WAS ALSO PRESCRIBED AMOXICILLIN AND CLAVULANATE POTASSIUM. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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 56 YR Female Required Intervention EXPLANTED:| IMPLANTED: | LEAD: MODEL 3093, LOT# V666023.| PROGRAMMER: MODEL 3037, LOT# NJD118252N.| PROGRAMMER: MODEL 3037, LOT# NJD118252N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT# V666023