BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3902818 · Received June 30, 2014

    Report

    Report Number
    3004209178-2014-12284
    Event Type
    Injury
    Date Received
    June 30, 2014
    Report Date
    June 5, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V254778, IMPLANTED: 2009 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3037, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT EARLY TO (B)(6), THE PATIENT HAD THEIR ORIGINAL IMPLANTABLE NEUROSTIMULATOR (INS) REPLACED DUE TO NORMAL BATTERY DEPLETION. ¿LIKE 2 WEEKS LATER¿ THE PATIENT HAD A SECOND SURGERY TO CLEAN OUT THE INCISION AND THEY ¿RECLAMPED THE CUT¿ BECAUSE, THE COVERING OR THE MIDDLE PART OF THE INCISION BROKE AND THE PATIENT STARTED BLEEDING. IT WAS NOTED THAT THE HEALTH CARE PROVIDER (HCP) WANTED TO MAKE SURE IT WAS CLEANED OUT GOOD IN THE OPERATING ROOM (OR). IT WAS TIGHTER THAN IT WAS BEFORE AND THE LITTLE BOX WAS CLOSER TO THE SKIN. IT WAS REPORTED THAT THE PATIENT THOUGHT THAT THE CLEANING KIND OF DISTURBED IT BECAUSE, THE OLDER SKIN WAS THINNER. THE PATIENT WAS GIVEN A ¿NEW METER¿ WHICH SURPRISED THEM BECAUSE, THE OTHER ONE WAS FINE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT TOMORROW TO ¿TAKE PLANTS OUT.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379344 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention