BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2841642 · Received November 21, 2012

    Report

    Report Number
    3004209178-2012-10610
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 23, 2012
    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
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3889-28, LOT# VA0199D, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT COMPLAINED OF PAIN AT THE INCISION SITE. THE REPORTER STATED THAT THE INCISION SITE WAS CHECKED BY THE HEALTH CARE PROFESSIONAL (HCP) IN THE MIDDLE OF OCTOBER AND THERE WERE NO ISSUES. IT WAS REPORTED BY THE HCP A WEEK TO TWO WEEKS LATER THAT THE INCISION SITE "PUSSED OUT" AND THAT THE DEVICE COULD BEEN SEEN THROUGH THE SKIN. IT WAS STATED THAT THE DEVICE "ERODED" AND THAT THE SYSTEM WAS TO BE REMOVED (B)(6) 2012. THE REPORTER STATED THAT THE PATIENT WAS "VERY THIN". IT WAS NOTED THAT THE MANUFACTURER REPRESENTATIVE MET WITH THE PATIENT IN MID-OCTOBER BECAUSE ONE PROGRAM CAUSED PAIN. IT WAS ALSO NOTED THAT SAID PROGRAM WAS "SHUT OFF." THE REPORTER ALSO STATED THAT THERAPY WAS HELPING THE PATIENT WITH SYMPTOMS AND REPROGRAMMING RESOLVED THE ISSUE. SUBSEQUENT INFORMATION REPORTED CONFIRMED INFECTION AT THE INCISION SITE. IT WAS STATED THAT THE INFECTION OCCURRED 3 MONTHS POST IMPLANT. IT WAS ALSO CONFIRMED THAT THE DEVICE AND LEAD WERE EXPLANTED, THE EXACT DATE WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A FOLLOW-UP REPORT.

    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