BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4157192 · Received October 9, 2014

    Report

    Report Number
    3004209178-2014-18633
    Event Type
    Injury
    Date Received
    October 9, 2014
    Report Date
    September 17, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3093-28, LOT# V230969, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3093-28, LOT# V230969, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3058, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7489, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE: EXTENSION; PRODUCT ID 3093-28, LOT# V230969, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT; PRODUCT ID 3093-28, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). THIS DEVICE IS INCLUDED IN THE MEDICAL DEVICE CORRECTION, "UNRETRIEVED DEVICE FRAGMENTS MODELS 3093 AND 3889 INTERSTIM TINED LEA DS", EDUCATIONAL BRIEF/PHYSICIAN COMMUNICATION (DECEMBER 2010).

    Description of Event or Problem · 1

    IT WAS REPORTED THE HEALTHCARE PROVIDER WAS REMOVING THE INTERSTIM DEVICE AND LEADS ON (B)(6) 2014 AND THE RIGHT SIDE LEAD BROKE OFF WHEN HE WAS TRYING TO TAKE IT OUT. THE REPORTER PLANNED TO IMAGE THE LEAD, MOST LIKELY USING X-RAY, AND THEN HAVE A NEUROLOGIST DISSECT AND REMOVE IT. THE HEALTHCARE PROVIDER SPOKE ABOUT THE PATIENT AND A CONCERN ABOUT THE PATIENT¿S BLOOD PRESSURE BEING WATCHED DURING PROCEDURES. ISSUE REGARDING THE PATIENT'S BLOOD PRESSURE WAS NOT FURTHER CLARIFIED. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT. SEE ALSO MANUFACTURER'S REPORT # 3004209178-2014-18632.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636486 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Required Intervention