BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 5806210 · Received July 19, 2016

    Report

    Report Number
    3004209178-2016-14501
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    January 1, 2015
    Report Date
    August 22, 2016
    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
    ME, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3093-28, LOT # V032633, IMPLANTED: (B)(6) 2007, 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

    ADDITIONAL INFORMATION REPORTED THAT THE PATIENT¿S IRRITATION JUST BEGAN OUT OF THE BLUE AND HAD A ¿LIGHT BLACK AND BLUE OVER THE IMPLANT SITE. THE PATIENT ALSO RESTATED THAT THEIR LEAD DISCONNECTED BY ITSELF. THE PATIENT QUESTIONED WHY THEY WERE FEELING ¿SOMETHING PRICKED¿ WHERE THEIR DEVICE WAS. THE LEAD WAS EITHER ON THE DEVICE OR BESIDE IT. THE PATIENT WANTED THEIR ENTIRE DEVICE REMOVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THERE WAS ITCHING AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND THE PATIENT COULD FEEL THAT THE LEADS WERE NO LONGER CONNECTED TO THE INS. THERE WAS NO TRAUMA OR FALL THAT COULD BE RELATED TO THIS ISSUE. HER HEALTHCARE PROFESSIONAL (HCP) TOLD HER TO CALL THE MANUFACTURER. THE PATIENT WAS GOING TO CALL THE HCP BACK. THE ITCHING AT THE INS SITE WAS SUDDEN. THE INS SITE WAS CURRENTLY BLACK AND BLUE. THE ITCHING STARTED ¿PROBABLY 6 MONTHS AGO¿ AND NOTED TO BE IN 2015 WHEN SHE WAS ASKED TO CLARIFY. THE LEADS NO LONGER BEING CONNECTED TO THE INS STARTED ¿A MONTH OR 2¿ AGO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459339 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3023

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR