BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6095995 · Received November 11, 2016

    Report

    Report Number
    3004209178-2016-23774
    Event Type
    Injury
    Date Received
    November 11, 2016
    Date of Event
    October 21, 2016
    Report Date
    November 11, 2016
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS: PRODUCT ID 3093-28, LOT# VA03ZV2, IMPLANTED: (B)(6) 2015, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM. IT WAS REPORTED THAT IMPEDANCE WAS ON ALL ELECTRODE CONFIGURATION. THE PATIENT HAD A RETURNED OF SYMPTOMS. IT WAS ALSO REPORTED THAT THE LEAD WAS BROKEN IN TWO AND BROKE AT THE ENTRY POINT TO THE INS. THE LEAD WAS ALSO TWISTED. THE DEVICE WAS REPLACED AND THE PATIENT WAS DOING WELL. THERE WAS NO VISIBLE OR SENSORY INJURY TO PATIENT. THE ISSUE WAS REPORTED RESOLVED AND THE PATIENT STATUS WAS ALIVE NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    747288 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention