BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2082817 · Received May 3, 2011

    Report

    Report Number
    3004209178-2011-03213
    Event Type
    Injury
    Date Received
    May 3, 2011
    Report Date
    April 13, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICE ANALYSIS WAS PERFORMED; THE DEVICE MET RISK-BASED ANALYSIS CRITERIA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD THEIR NEUROSTIMULATOR EXPLANTED DUE TO THE NEED TO HAVE AN MRI. NO PT INJURIES WERE REPORTED.

    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 Required Intervention IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD055716N| LEAD: MODEL 3889, LOT# V059468