BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2212632 · Received August 11, 2011

    Report

    Report Number
    3004209178-2011-06254
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 18, 2011
    Report Date
    July 8, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, 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 BEEN EXPERIENCING MIGRAINES AND VERTIGO FOR THE PAST 6 MONTHS, AND NEEDED TO HAVE AN MRI OF HER HEAD. THEREFORE, THE NEUROSTIMULATOR WAS EXPLANTED. A NEUROSTIMULATOR WAS GOING TO BE REIMPLANTED ON (B)(6) 2011.

    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 46 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD109028N| LEAD: MODEL 3889, LOT# V487230| EXPLANTED: