BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4814706 · Received June 3, 2015

    Report

    Report Number
    3004209178-2015-10168
    Event Type
    Injury
    Date Received
    June 3, 2015
    Date of Event
    October 10, 2012
    Report Date
    May 13, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V913910, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3093-28, LOT# V913910, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT NEVER HAD THERAPEUTIC EFFECT. THE PATIENT¿S IMPLANT NEVER WORKED FOR HER AND SHE HAD IT REMOVED DUE TO LIVER DISEASE AND THE DOCTORS WANTING TO REMOVE HER IMPLANTED DEVICES. IT WAS FURTHER REPORTED THAT THE LEAD REMAINED IMPLANTED AND WAS EMBEDDED IN SCAR TISSUE. THE PATIENT HAD LIVER DISEASE. THERE WAS NO SPECIFIC DEVICE ALLEGATION MENTIONED BUT THIS OCCURRED AFTER THE IMPLANT. NO OUTCOME OR INTERVENTION REGARDING THIS EVENT WAS REPORTED. FURTHER FOLLOW- UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW- UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358851 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00038 YR Life Threatening| O