BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 4918065 · Received July 16, 2015

    Report

    Report Number
    3004209178-2015-13482
    Event Type
    Malfunction
    Date Received
    July 16, 2015
    Date of Event
    May 30, 2015
    Report Date
    June 26, 2015
    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
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3 093-28, LOT# V890309, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE DEVICE NOT WORKING WAS THAT THE INS WAS TURNED OFF. AS A RESULT, THE INS WAS TURNED ON TO TRY THERAPY AGAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD MADE AN APPOINTMENT WITH HER HEALTH CARE PROVIDER (HCP) FOR (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) HAD LOST THERAPY AND HAD NOT BEEN WORKING SINCE (B)(6) 2015. THE PATIENT ALSO STATED THAT THEY "QUIT WEARING HER DEVICE" (B)(6) 2015. IT WAS ALSO NOTED THAT THE PROGRAMMER UNIT WAS NOT WORKING. THE PATIENT PUT IN NEW BATTERIES BUT STILL SHOWED A LOW BATTERY AND GOT A POOR COMMUNICATION SCREEN. HOWEVER, THE PATIENT WAS ABLE TO CONNECT TO THE INS ON THE FIRST TRY AT THE TIME OF REPORT. THE PROGRAMMER DID SHOW THAT THE BATTERY WAS FULL (THE BATTERY ICON WAS ALL BLACK) WHICH THEY HAD BEEN TAKING AS INDICATING A LOW BATTERY. THE PATIENT DID NEED A NEW PHYSICIAN AS THEIR PREVIOUS DOCTOR HAD MOVED. THERE WERE NO FURTHER DETAILS, INTERVENTIONS OR AN OUTCOME WAS 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
    464390 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1