BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 3851709 · Received June 5, 2014

    Report

    Report Number
    3004209178-2014-10199
    Event Type
    Injury
    Date Received
    June 5, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO.,
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3031A, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: 2004 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3889-28, LOT# J0357419V, IMPLANTED: 2004 (B)(6); PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT STATES THAT SHE CANNOT CONNECT TO HER INS (STIMULATOR) FOR THE PAST WEEK. THE PATIENT STATES, SHE ONLY SEES THE BOTTOM LIGHT FOR THE PROGRAMMER BATTERY ILLUMINATED - NO OTHER LIGHTS. THE PATIENT REPORTS A LOSS OF THERAPEUTIC EFFECT. THE PATIENT HAS HAD SYMPTOM RETURN FOR THE PAST 2 WEEKS. THE PATIENT WAS GOING TO THE BATHROOM EVERY 20 MINUTES AND SHE GOT HER FIRST BLADDER INFECTION SINCE THE IMPLANT OF THE DEVICE LAST WEEK. THE PATIENT REPORTS NO STIMULATION SENSATION. ADDITIONAL INFORMATION RECEIVED REPORTS ABOUT ONE MONTH AGO THE PATIENT SAID HER INS(STIMULATOR) DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329408 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO., 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 00063 YR Required Intervention