BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 4942944 · Received July 27, 2015

    Report

    Report Number
    3004209178-2015-14114
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 6, 2015
    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 PRODUCTS: PRODUCT ID: 3093-33, LOT# V179210, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE HEALTH CARE PROVIDER (HCP) WAS REMOVING THE LEAD, THE LEAD BROKE. THE HCP TRIED TO REMOVE THE BROKEN LEAD FROM THE SACRUM, BUT WAS UNABLE TO REMOVE IT. THE BROKEN LEAD WAS LEFT IN THE PATIENT AND WAS REPLACED. THE ISSUE WAS NOT RESOLVED. THE LEAD WOULD NOT BE RETURNED AS IT WAS DISCARDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486584 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00031 YR Other