BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3822328 · Received May 20, 2014

    Report

    Report Number
    3004209178-2014-09325
    Event Type
    Injury
    Date Received
    May 20, 2014
    Report Date
    May 1, 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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0GMU1, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_PROG, PRODUCT TYPE: PROGRAMMER, PHYSICIAN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT HAD HER INTERSTIM EXPLANTED YESTERDAY (B)(6) 2014. THE PATIENT HAD THE DEVICE EXPLANTED BECAUSE IT DIDN'T WORK AND IT WAS PAINFUL AT THE IMPLANT SITE, IN HER BUTTOCK, AND DOWN INTO THE HIP, LEG, AND FOOT. THE PATIENT COULDN'T SLEEP DUE TO THE PAIN. THE PATIENT DESCRIBED IT AS BOTH A PAINFUL AND A HOT/BURNING SENSATION. THE PATIENT EXPERIENCED NAUSEA. THE PATIENT HAD NONE OF THESE SYMPTOMS FROM THE TRIAL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298764 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention