BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2601693 · Received June 6, 2012

    Report

    Report Number
    3004209178-2012-04106
    Event Type
    Injury
    Date Received
    June 6, 2012
    Report Date
    May 8, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V800432, IMPLANTED: (B)(6) 2011, EXPLANTED: NA. PRODUCT TYP LEAD PRODUCT ID 3037, LOT# SERIAL# (B)(4), PRODUCT TYP PROGRAMMER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION FOLLOWING THE IMPLANTATION OF AN IMPLANTABLE NEUROSTIMULATOR (INS) ON (B)(6) 2011. THE PATIENT'S STITCHES POPPED OPEN ABOUT ONE WEEK AFTER THE OPERATION AND THE INFECTION DEVELOPED AT THE INS POCKET SITE ON THE RIGHT BUTTOCK. THE INFECTION PRESENTED WITH "OOZING," WARMNESS, AND TENDERNESS. THE INS WAS EXPLANTED ON (B)(6) 2012 AND A NEW INS WAS IMPLANTED AT A DIFFERENT SITE. THE PATIENT NOTED THAT THE ORIGINAL POCKET INCISION WAS TREATED WITH SILVER NITRATE AND DRESSINGS AND TOOK ABOUT THREE MONTHS TO HEAL. THE INCISION HEALED COMPLETELY BUT LEFT A SCAR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention