BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3129959 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08181
    Event Type
    Injury
    Date Received
    May 24, 2013
    Report Date
    May 2, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V800432, IMPLANTED: (B)(6) 2011, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3037, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR REVEALED A "SUSPECTED BODY FLUID WAS IN THE CONNECTOR PORT."

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE TESTING WAS PERFORMED INTRAOPERATIVE. THERE WAS NO PATIENT DEATH OR INJURY ASSOCIATED WITH THE EVENT. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REPLACED AND NOT USED BECAUSE THERE WAS ¿DEBRIS¿ IN THE HEADER BLOCK. ABOUT TWO WEEKS LATER AN IMAGE WAS RECEIVED THAT DISPLAYED HIGH IMPEDANCES ON THREE BIPOLAR PAIRS: 0 AND 1, 1 AND 2, AND 1 AND 3. FOUR DAYS LATER IT WAS REPORTED THAT THE DEVICE AND LEAD WERE REPLACED. THE DEBRIS LOOKED LIKE BLOOD AND SKIN TISSUE. IT WAS REPORTED THAT THE LEAD WAS REPLACED FIRST AND THE SYSTEM STILL HAD HIGH IMPEDANCES. THE DEVICE WAS THEN REPLACED AND THE IMPEDANCES WERE ¿FINE.¿ THE PATIENT WAS DOING WELL WITH THE NEW SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231409 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention