BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM

    MDR report key: 5383725 · Received January 21, 2016

    Report

    Report Number
    6000153-2016-00183
    Event Type
    Injury
    Date Received
    January 21, 2016
    Date of Event
    December 17, 2015
    Report Date
    March 30, 2016
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT IT WAS UNCLEAR WHAT THE CAUSE OF THE DEVICE NOT WORKING, THE LEAD BREAKING, AND THE PATIENT NOT FEELING STIMULATION WAS. IT WAS DETERMINED THAT THE DEVICE WAS NOT WORKING BY "DAH" AND THE PATIENT'S CLINICAL RESPONSE. THE LEAD BREAK WAS CONFIRMED. THE ACTION REQUIRED TO RESOLVE THE DEVICE NOT WORKING, BROKEN LEAD, AND THE PATIENT NOT FEELING STIMULATION WAS THAT THEY PLANNED TO REMOVE AND REPLACE THE DEVICE. THE PATIENT WAS NOT DOING WELL.

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THE PATIENT¿S DEVICE WAS NOT WORKING. THE PATIENT WENT TO SEE THEIR HEALTH CARE PROVIDER (HCP) ON (B)(6) 2015 AND THEY USED IT TO SEE IF IT WAS WORKING. THE PATIENT WASN¿T FEELING STIMULATION AND THE HCP BELIEVED THERE WAS A BREAK IN THE LEAD. THE PATIENT HAD NO FALLS WITH THEIR CURRENT IMPLANT. THE PATIENT WAS HAVING TROUBLE WITH INSURANCE, BUT THEY WERE IN CONTACT WITH THE MANUFACTURER REPRESENTATIVE AND HCP¿S OFFICE. THE PATIENT WAS TRYING TO FIGURE OUT WHAT THEY NEEDED TO DO AS FAR AS BEING ABLE TO GET THE SURGERY DONE. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. NO INTERVENTIONS 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
    41695 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3889-28 VA0LZ33

    Patients

    Seq Age Sex Outcome Treatment
    1 00041 YR Required Intervention