BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3120704 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07923
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 29, 2013
    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
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# V054411, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3889-28, LOT# V008733, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    AFTER ADDITIONAL REVIEW, IT WAS NOTED THAT THE STIMULATOR DID NOT WORK AS GOOD AS THE FIRST ONE. IT WAS ALSO NOTED THAT THE PATIENT HAD AN OPTION OF FOUR PROGRAMS. THE PATIENT WAS NOT ABLE TO FIND ANY PROGRAMS OUT OF THE FOUR THAT WORK WELL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S DEVICE WAS INFECTED AND HAD TO BE REMOVED. THE REPORTER INDICATED THAT THE LEADS WERE LEFT IMPLANTED AND ¿THEY HAD TO GO BACK IN¿ TO REMOVE THEM TO ALLOW THE WOUND TO HEAL ENTIRELY. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222481 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention