BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 5003879 · Received August 14, 2015

    Report

    Report Number
    3004209178-2015-16032
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Report Date
    July 22, 2015
    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
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT# VA0WB5Q, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4) PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTHCARE PROFESSIONAL (HCP) REPORTED THAT THE PATIENT WAS UNAWARE OF CALLING/ STATING SHE SAW POOR COMMUNICATION SCREEN. THE PATIENT WAS SEEN IN THE OFFICE ON 2015 (B)(6). PROGRAM AND INTENSITY WAS ADJUSTED AND THE PATIENT STATED THEY WERE NOT HAVING ANY TROUBLE AND THE DEVICE WAS WORKING WELL.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THERE WAS POOR COMMUNICATION SEEN ON THE PATIENT PROGRAMMER. THE PATIENT WAS RECENTLY IMPLANTED BUT THERE WAS NO BANDAGES OR SWELLING PRESENT. THE ANTENNA WAS USED. IT WAS CONFIRMED THAT THE ANTENNA WAS SECURE AND THEY MOVED AWAY FROM ANY SOURCE OF POTENTIAL ELECTROMAGNETIC INTERFERENCE (EMI). THIS DID NOT RESOLVE THE ISSUE. THE PATIENT REPORTED AN ACCIDENT THAT WAS SUDDEN. THE INDICATION-FOR-USE (IFU) WAS URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/PELVIC FLOOR. NO OUTCOME OR INTERVENTION WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    539782 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR