BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3941210 · Received July 17, 2014

    Report

    Report Number
    3004209178-2014-13161
    Event Type
    Injury
    Date Received
    July 17, 2014
    Report Date
    June 26, 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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA04V0N, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), (B)(6) IMPLANTED, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF THEIR PELVIC PAIN FROM THEIR IMPLANTABLE NEUROSTIMULATOR (INS) WHICH STARTED ABOUT 4 WEEKS AGO. THERE WERE NO FALLS OR TRAUMA REPORTED THAT WERE ASSOCIATED WITH THE ISSUE. THE PATIENT DID STATE THAT THEY WERE AT CHOIR PRACTICE AND FELT IT COME ON, WENT HOME, AND WAS IN THE FETAL POSITION ON THE FLOOR FROM THE PAIN. IT WAS NOTED THAT, IN THE BEGINNING, THE INS HAD HELPED A LOT WITH THE PELVIC PAIN. THE PATIENT HAD BEEN TO THEIR HEALTHCARE PROFESSIONAL (HCP) REGARDING THE ISSUE AND BEEN TAKING BLADDER TREATMENTS/SHOTS AGAIN. FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT STILL HAD CONCERNS REGARDING THEIR DEVICE THERAPY BUT WAS WORKING WITH THEIR DOCTOR AND THE MANUFACTURER¿S REPRESENTATIVE. THERE WAS NO SET DATE FOR AN APPOINTMENT. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THERE WERE NO ABNORMAL IMPEDANCE MEASUREMENTS. IT WAS STATED THAT THE ISSUE WITH THE INS OR LEAD WAS UNKNOWN AND THE PATIENT PROGRAMMER WAS DETERMINED TO BE FUNCTIONING APPROPRIATELY. IT WAS NOTED THAT SURGICAL INTERVENTION OF EXPLANT OF THE IMPLANTABLE NEUROSTIMULATOR (INS) AND LEAD TOOK PLACE ON (B)(6) 2014. THE DEVICES WOULD NOT BE RETURNED TO THE MANUFACTURER FOR ANALYSIS AND THE HEALTH CARE PROVIDER (HCP) HAD CONTACTED THE MANUFACTURER REPRESENTATIVE AND WAS TOLD THERE WAS NO REASON TO RETURN IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    419023 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention