BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1895255 · Received November 8, 2010

    Report

    Report Number
    3004209178-2010-09074
    Event Type
    Injury
    Date Received
    November 8, 2010
    Date of Event
    August 18, 2010
    Report Date
    October 19, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE IMPLANTABLE NEUROSTIMULATOR AND LEAD HAVE BEEN RETURNED TO THE MFR FOR ANALYSIS. A F/U REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT'S LEAD WAS NOT TRANSFORAMINAL. THE IMPLANTABLE NEUROSTIMULATOR AND LEAD WERE EXPLANTED AND REPLACED. NO PT SYMPTOMS OR OUTCOMES WERE REPORTED. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADDITIONAL INFO 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 78 YR Required Intervention EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093BLUE_LEAD, LOT# V432837| PROGRAMMER: MODEL 3037, LOT# NJD104556N| EXPLANTED:| IMPLANTED: