BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4152745 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18551
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 22, 2014
    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: 3093-28, LOT# V870676, IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEADS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE (TINED LEAD) (V870676) REVEALED LEAD BODY CONDUCTOR BROKEN AT OR NEAR TINES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PHYSICIAN TRIED TO REMOVE THE LEAD, THE LEAD BROKE WHERE THE TINES BEGIN. IMPEDANCES GREATER THAN 4000 OHMS WERE NOTED ON ALL ELECTRODES. THE PARTIAL LEAD WAS LEFT IN THE PATIENT'S LEFT S3 NERVE FORAMINA. THE REPLACEMENT LEAD WAS PLACED IN THE PATIENT'S RIGHT S3 NERVE FORAMINA. THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS ALIVE WITH NO INJURY. IT WAS NOTED THAT THE PATIENT WAS RECEIVING PROPER STIMULATION WITH THE NEW LEAD AND IMPLANTABLE NEUROSTIMULATOR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631163 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00071 YR Other