BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2830139 · Received November 13, 2012

    Report

    Report Number
    3004209178-2012-10196
    Event Type
    Injury
    Date Received
    November 13, 2012
    Report Date
    October 16, 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
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 355018 LOT# W60030, PRODUCT TYPE ACCESSORY. ANALYSIS OF THE RETURNED PORTION OF THE INTRODUCER SHEATH MODEL 355018 LOT FOUND THAT THE MARKER BAND HAD SEPARATED FROM THE SHEATH AND THE DISTAL END OF THE SHEATH WAS STRETCHED. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID, NEU_UNKNOWN, PRODUCT TYPE UNKNOWN PRODUCT ID, 3889-28 LOT# VA01NGX, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS DETERMINED THAT THE FRAGMENT OF THE INTRODUCER SHEATH WOULD CAUSE THE PATIENT NO HARM IF LEFT BEHIND. THE ALTERNATIVE WOULD BE A MAJOR SURGERY TO HAVE THE FRAGMENT REMOVED. THE DECISION WAS MADE TO LEAVE THE FRAGMENT AND CONTINUE ON WITH THE CASE. THERE WAS NO PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING LEAD INTRODUCTION A PIECE OF SHEATH WAS SHEARED OFF AND REMAINED IN THE PATIENT. THE GUIDE WIRE, INTRODUCER, AND SHEATH WERE INSERTED AND UPON REMOVAL OF THE INTRODUCER AND GUIDE WIRE, "LITTLE BLEEDING OCCURRED." REINTRODUCTION OF THE METAL INTRODUCER INTO THE SHEATH LED TO THE FRAGMENTATION OF THE SHEATH. IT WAS REPORTED THAT INVASIVE SURGERY WOULD HAVE BEEN REQUIRED TO RETRIEVE THE PIECE AND IT WAS SITTING BETWEEN ELECTRODE CONTACTS AND TINES. A DAY LATER IT WAS REPORTED THAT FLUOROSCOPIC IMAGES TAKEN SHOWED THE "RADIO OPAQUE" MARK LEFT IN THE PATIENT. IT WAS REPORTED THAT THE DISTAL PORTION, ABOUT 3 MILLIMETERS OF PLASTIC, BROKE OFF OF THE INTRODUCER AND WAS LEFT IN THE PATIENT. NO INTERVENTIONS HAVE TAKEN PLACE OR BEEN PLANNED. THE PATIENT WAS RECEIVING EFFECTIVE THERAPY AND FELT APPROPRIATE STIMULATION. AN IMPEDANCE CHECK SHOWED NOTHING ABNORMAL.

    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 Other