BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2223872 · Received August 18, 2011

    Report

    Report Number
    3004209178-2011-06531
    Event Type
    Injury
    Date Received
    August 18, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 29, 2011
    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
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT STATED THEY WERE NOT INFORMED OF AN MRI RESTRICTION PRIOR TO IMPLANT. IT WAS REPORTED THAT THE PT VISITED THEIR DOCTOR REGARDING THE EVENT. THE PT HAD A SURGICAL INTERVENTION TO EXPLANT THEIR DEVICE 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 61 YR Required Intervention LEAD: MODEL 3093, LOT# V268625| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD088370N