BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4132876 · Received October 1, 2014

    Report

    Report Number
    3004209178-2014-18094
    Event Type
    Injury
    Date Received
    October 1, 2014
    Report Date
    September 10, 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
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3 093-33, LOT# V649839, IMPLANTED: (B)(6) 2011, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN 2012 THE SYSTEM AGAIN NEEDED TO BE REMOVED DUE TO DEVICE MALFUNCTION. DURING THIS REMOVAL PROCESS THE LEAD WAS CUT LEAVING AN UNRETRIEVED DEVICE FRAGMENT. THE PATIENT¿S HEALTH CARE PROVIDER¿S (HCP¿S) OFFICE CONDUCTED RADIOGRAPHS CONFIRMING UNRETRIEVED DEVICE FRAGMENTS ON BOTH SIDES OF THE BODY AND THEY WERE INQUIRING ABOUT INFORMATION ON MRIS WITH UNRETRIEVED SACRAL NEUROMODULATION (SNM) DEVICE FRAGMENTS THAT THEY MAY SHARE WITH THE MRI CENTER. IT WAS UNKNOWN WHICH TYPE OF MRI OR WHICH PART OF THE BODY WAS TO BE SCANNED. 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. REFER TO MANUFACTURER¿S REPORT # 3004209178-2014-18086 FOR REPLACEMENT OF THE PATIENT¿S FIRST DEVICE AND MANUFACTURER¿S REPORT # 300 4209178-2014-18091 FOR UNRETRIEVED DEVICE FRAGMENTS FROM THE PATIENT¿S SECOND DEVICE REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    613247 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention