BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3693825 · Received March 21, 2014

    Report

    Report Number
    3004209178-2014-04860
    Event Type
    Injury
    Date Received
    March 21, 2014
    Report Date
    February 26, 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 3889-28, LOT# V220529, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4). 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).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LEAD TIP WAS DAMAGED DURING EXPLANT. IT WAS NOTED THE TIP OF THE LEAD INCLUDING FOUR DISTAL ELECTRODES, SHEATH, AND TINES WERE LEFT INTERNALIZED. IT WAS REPORTED THE INTERNAL WIRING OF THE LEAD CAME OUT. IT WAS NOTED THE SYSTEM WAS BEING REMOVED FOR AN MRI. IT WAS REPORTED THE PATIENT HAD RECOVERED. IT WAS NOTED THERE WERE NO PLANS TO REMOVE THE REMAINING PORTION OF THE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170273 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Other