BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3854183 · Received June 6, 2014

    Report

    Report Number
    3004209178-2014-10270
    Event Type
    Injury
    Date Received
    June 6, 2014
    Date of Event
    May 16, 2014
    Report Date
    May 18, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# VA0H3LQ, IMPLANTED: (B)(6) 2014, 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 WAS HAVING ISSUES WITH THEIR DEVICE AND WANTED ASSISTANCE TURNING IT OFF COMPLETELY. THE PATIENT STARTED HAVING PAIN FROM THE DEVICE 2 DAYS AGO AND THE PAIN FELT LIKE THE PAIN SIMILAR TO A URINARY TRACT INFECTION (UTI). IT WAS NOTED THAT THE PAIN WAS BURNING AND CAUSING A SENSATION OF ELECTRICITY SHOOTING THROUGH THEIR BODY AND THE PAIN WAS SO BAD. THE PATIENT HAD AN APPOINTMENT TOMORROW WITH THEIR HEALTH CARE PROVIDER (HCP) AND THE PATIENT SUCCESSFULLY TURNED THE DEVICE OFF WITH THEIR PROGRAMMER AND WOULD TALK TO THEIR HCP. IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED 5 DAYS AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331189 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR Required Intervention