BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4151834 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18491
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Report Date
    September 17, 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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, LOT# V475128, IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT THOUGHT THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING. THE PATIENT HAD A GRADUAL RETURN OF SYMPTOMS, LEAKING, AND THEY HAD NOT FELT STIMULATION FOR THE LAST TWO WEEKS. WHEN THE PATIENT TRIED TO ADJUST STIMULATION A DAY PRIOR TO THIS REPORT, THEY WERE NOT ABLE TO AND THEY SAW A PICTURE OF THE INS AND A BATTERY ON ITS SIDE. THE PATIENT WAS VERY SURE THAT THEY SAW THE INS THAT LOOKED LIKE A FOLDER AND THEN A BATTERY BECAUSE WHEN THEY TURNED THE PATIENT PROGRAMMER OFF AND BACK ON THEY SAW THE SAME PICTURE. THE PATIENT BELIEVED THE INS MAY BE DEAD AND THEIR HEALTHCARE PROFESSIONAL (HCP) TOLD THEM THAT THE INS SHOULD LAST ABOUT 10 YEARS. THE PATIENT WAS CONCERNED AS IT HAD ONLY BEEN ABOUT FOUR YEARS. THE PATIENT HAD NO FALLS OR TRAUMA AND THEY HAD CONTACTED THEIR HCP. NO INTERVENTIONS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. 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
    632912 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR