BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 1936208 · Received December 14, 2010

    Report

    Report Number
    3004209178-2010-10467
    Event Type
    Injury
    Date Received
    December 14, 2010
    Date of Event
    November 18, 2010
    Report Date
    December 9, 2010
    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
    WI, 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 HAD PAINFUL STIMULATION (INCLUDING VAGINAL PAIN) AND A RETURN OF SYMPTOMS. THE PT DECREASED THE AMPLITUDE AND THE VAGINAL PAIN RESOLVED. IT WAS FURTHER REPORTED THAT THE PT HAD SURGERY TO RESOLVE THE PROBLEM. NO DETAILS WERE PROVIDED REGARDING THE SURGERY. THE PT WAS NO LONGER HAVING ISSUES WITH HER SYSTEM. ADDITIONAL DETAILS WERE REQUESTED.

    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 72 YR Required Intervention IMPLANTED:| PROGRAMMER: MODEL 3037, LOT# NJD111386N| LEAD: MODEL 3889, LOT# V535750| EXPLANTED: