BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1940339 · Received December 20, 2010

    Report

    Report Number
    3004209178-2010-10598
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    September 30, 2010
    Report Date
    December 15, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    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

    IT WAS ORIGINALLY REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. SHE THEN MET WITH THE HEALTHCARE PROFESSIONAL AND THE COMPANY REP FOR THE EVENT. SHE HAD SURGERY TO FIX THE NEUROSTIMULATOR PROBLEM. SHE WAS STILL HAVING PROBLEMS WITH HER DEVICE SYSTEM.

    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 73 YR Required Intervention LEAD: MODEL 3093, LOT #: V519211| IMPLANTED:| PROGRAMMER: MODEL 3037, LOT #: NJD113742N| EXPLANTED: