BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3834817 · Received May 28, 2014

    Report

    Report Number
    3004209178-2014-09684
    Event Type
    Injury
    Date Received
    May 28, 2014
    Report Date
    May 6, 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
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-33, LOT # V072754, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3095-10, SERIAL # (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3031A, SERIAL # (B)(4), IMPLANTED: (B)(6) 2004, PRODUCT TYPE PROGRAMMER, PATIENT. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A DIFFERENT BATTERY PLACED IN (B)(6) 2014 BECAUSE THEIR DEVICE THAT WAS PLACED IN (B)(6) 2007 HAD NOT WORKED FOR A COUPLE OF YEARS. IT WAS STATED THEY WERE NOT ABLE TO HAVE THE DEVICE THAT WAS PLACED IN 2007 REMOVED DUE TO TISSUE THAT HAD GROWN OVER IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313437 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention