BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 2161801 · Received July 8, 2011

    Report

    Report Number
    3004209178-2011-05236
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    January 1, 2011
    Report Date
    June 13, 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
    NC, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PT EXPERIENCED PARALYSIS FROM THE WAIST DOWN. THE HEALTH CARE PROFESSIONAL MOVED THE IMPLANTABLE NEUROSTIMULATOR AND THIS RESOLVED THE ISSUE. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM EZW MDT PUERTO RICO OPERATIONS CO., JUNCOS 3023 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention