BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 5057042 · Received September 4, 2015

    Report

    Report Number
    3004209178-2015-17332
    Event Type
    Injury
    Date Received
    September 4, 2015
    Report Date
    August 12, 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
    MN, 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# V093120, IMPLANTED: (B)(6) 2008, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) REPORTED THAT THE PATIENT HAD A FALL AND LOSS OF STIMULATION; IT WAS UNKNOWN WHEN THIS OCCURRED. THE IMPEDANCES WERE MEASURED AND ALL OF THE PAIRS WERE GREATER THAN 4,000 OHMS. THE LEADS WERE REPLACED AND THIS NORMALIZED ALL OF THE IMPEDANCES, SO IT WAS ASSUMED THE LEAD WAS THE SOURCE OF THE HIGH IMPEDANCES. THE PATIENT RECOVERED COMPLETELY AND SHE FELT STIMULATION AGAIN IN THE TARGET AREA. THE PATIENT'S INDICATIONS FOR USE WERE URINARY DYSFUNCTION, SACRAL NERVE STIMULATION, AND GASTROINTESTINAL/PELVIC FLOOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587734 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention