BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6243902 · Received January 11, 2017

    Report

    Report Number
    3004209178-2017-00668
    Event Type
    Injury
    Date Received
    January 11, 2017
    Date of Event
    October 19, 2016
    Report Date
    January 11, 2017
    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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3889-28 ,LOT# V842736, PRODUCT TYPE LEAD. CODES (B)(4) APPLIES TO THE 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 PROVIDER (HCP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR GASTROIN TESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE DEVICE WAS PLACED ON (B)(6) 2014. THE REASON FOR CALL WAS TO ASK IF PROCEDURE NEEDED TO BE DONE IN THE HOSPITAL OR IF AN AMBULATORY SURGERY CENTER WAS OK AND ALSO INQUIRE HOW LONG THE IMPLANTABLE NEUROSTIMULATOR (INS) LAST. A LEAD MIGRATION WAS NOTED. HCP STATED PATIENT NEEDED REVISION SURGERY AS THEY RECENTLY DEVELOPED URGENCY OR THERE WAS CONCERNED ABOUT THE LEAD MIGRATION. HCP INITIALLY INDICATED THE ¿INTERSTIM 2¿ PART NEEDED TO BE REDONE. HCP WAS READING FROM PATIENT¿S NOTES WHICH INDICATED PATIENT WISHED TO HAVE "EUA AND REPLACEMENT OF LEADS IF MISPLACED". HCP SUSPECTED ELECTRODES MAY HAVE MIGRATED OFF THE NERVE. HCP CONTINUED TO READ FROM (B)(6) 2016 APPOINTMENT NOTES THAT PATIENT HAD IMPLANT IN (B)(6) 2014 AND HAS BEEN HAPPY UNTIL NOW. THE PROGRAM 3 WAS RESET TO 5.1V AND PATIENT WAS ON PROGRAM 2 AT 3.7V. PATIENT HAD 5 WET PADS A DAY AND THERE WAS NO RESPONSE FROM THE "TRIAL MONITOR". FROM DISCUSSION ON THE CALL IT APPEARED THE HCP WAS REFERRING TO THE PATIENT PROGRAMMER AS THE "TRIAL MONITOR". PATIENT RETURNED FOR APPOINTMENT ON (B)(6) 2016 AND INDICATED SOMETHING WAS DEFINITELY OFF, ISSUE HADN'T IMPROVED AND THEY FELT THAT THEIR SYMPTOMS ARE LIKE THEY WERE PRIOR TO IMPLANT BUT NOCTURIA REMAINS MUCH IMPROVED AND ONLY CONCERN WERE URGENCY AND WET PADS. IT WAS ALSO REPORTED PATIENT EXPERIENCED SUDDEN SYMPTOM RETURN OF URGENCY. PATIENT HAD TO LEAVE THE COUNTRY AND WAS BACK (B)(6) WITH THE SAME ISSUE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26710 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention