BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3173707 · Received June 17, 2013

    Report

    Report Number
    3004209178-2013-10490
    Event Type
    Injury
    Date Received
    June 17, 2013
    Report Date
    May 28, 2013
    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
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V575376, IMPLANTED: (B)(6) 2010, EXPLANTED: (B)(6) 2013. 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 THE PATIENT DEVELOPED AN INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE. THE INFECTION HAD NOT BEEN CONFIRMED AT THE TIME, AS THE CULTURE HAD JUST BEEN SENT. THE PATIENT ALSO EXPERIENCED POCKET DISCOMFORT. THE REPORTER INDICATED THAT THE INS WAS LOW. HOWEVER, THERE WAS NO COMPLAINT ABOUT INS DEPLETION. IT WAS NOTED THAT THE INS AND LEAD HAD BEEN EXPLANTED. AT THE TIME OF THE REPORT, THE PATIENT WAS UNDER THE CARE OF THE HEALTHCARE PROVIDER. THE FOLLOWING DAY, THE REPORTER HAD NOT OBTAINED ANY RESULTS FROM THE CULTURE. THE PATIENT WAS REPORTEDLY DOING ¿FINE¿ AND PLANNED TO HAVE A NEW SYSTEM IMPLANTED. HOWEVER, A NEW DATE HAD NOT BEEN SCHEDULED YET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S BATTERY WAS DEPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273988 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention