BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2994349 · Received March 8, 2013

    Report

    Report Number
    3007566237-2013-00725
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 22, 2013
    Report Date
    August 20, 2018
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID NEU_UNKNOWN_LEAD, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 RECEIVED REPORTED THAT A DIFFERENT DEVICE WAS USED AND IMPLANTED. THERE WERE NO IMPEDANCES AND THE PATIENT WAS DOING WELL. THE ORIGINAL EVENT WAS REPORTED TO HAVE HAPPENED THREE TIMES SO IT WAS UNCLEAR WHICH EVENT THE FOLLOW UP INFORMATION PERTAINED TO. IT WAS UNCLEAR IF IT APPLIED TO EACH PATIENT OR ONLY TO ONE OF THE THREE. REFER TO MANUFACTURING REPORT #3007566237-2013-00724 AND #3007566237-2013-00726 FOR THE TWO RELATED EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER (HCP) HAD DIFFICULTY ADVANCING THE LEAD INTO THE IMPLANTABLE NEUROSTIMULATOR CONNECTOR BLOCK. IT WAS STATED THE HCP TRIED TO INSERT THE LEAD FOR ABOUT 5-10 MINUTES. WHEN THE LEAD WAS IN PLACE, IMPEDANCES WERE MEASURED AND "MULTIPLE PAIRS WERE OUT OF RANGE." THE INFORMATION REASONABLY SUGGESTED THE INS WAS NOT IMPLANTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WERE TWO IMPLANTABLE NEUROSTIMULATORS (INS) USED. ONE WAS SENT BACK FOR ANALYSIS AND THE OTHER ONE WAS IMPLANTED BY THE PHYSICIAN. IT WAS NOTED THAT 3 EVENTS OF DIFFICULTY ADVANCING THE LEAD INTO THE HEADER BLOCK WERE MENTIONED BECAUSE THE IMPEDANCE PROBLEM HAD BEEN SOMETHING THAT "CAME UP MULTIPLE TIMES THAT MONTH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99669 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC NEUROMODULATION 3058

    Patients

    Seq Age Sex Outcome Treatment
    1