BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3912468 · Received July 3, 2014

    Report

    Report Number
    3004209178-2014-12493
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    November 13, 2013
    Report Date
    June 12, 2014
    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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3093-28, LOT# VA0DC8Q, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_PT M_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RECENTLY, A COUPLE OF MONTHS AGO, THE PATIENT WAS DIAGNOSED WITH SKIN LUPUS AND NOT THE SYSTEMIC KIND THAT AFFECTED INTERNAL ORGANS BUT JUST ON THEIR SKIN. THE PATIENT HAD A RASH ON THEIR BACK THAT GOT WORSE AFTER THEY PUT THE IMPLANT IN AND THEY WERE TREATING IT AND IT WAS GETTING BETTER. IT WAS NOTED THAT THE DEVICE WAS ON TOP OF THE SKIN AND IT WAS NOT VERY DEEP. THE PATIENT¿S HEALTH CARE PROVIDER (HCP) TOLD THEM THAT IT WAS PROBABLY NOT RELATED TO THE DEVICE BUT THE FACT THAT THEY HAD A LITTLE SURGERY THERE PROBABLY CAUSED IT. IT WAS REPORTED THAT IT WAS JUST A COINCIDENCE THAT THE SURGERY TO CUT SKIN WAS SO CLOSE TO WHERE IT WAS AND IT GOT MUCH BETTER NOW. THE PATIENT STILL HAD THE RASH BUT IT DID NOT ITCH OR HURT. IT WAS NOTED THAT IT WAS UP AND DOWN THE CENTER OF THE PATIENT¿S BACK AND IT WAS MUCH BETTER SINCE THEY GAVE THE PATIENT THE PILL FOR LUPUS. PART OF THE RASH WAS GONE AND CLEARED UP WITH THE PILLS AND IT WAS NOT GONE COMPLETELY AND THE PART UP AND DOWN THE PATIENT¿S BACK WAS A FOURTH OF WHAT IT WAS. IT WAS NOTED THAT THE PATIENT HAD A LOT OF ALLERGIES FOR THE LAST 10 YEARS AND THEY TRIED ALL KINDS OF MEDICATIONS AND THE HCPS COULD NOT FIX THEIR ALLERGIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391087 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR Required Intervention