BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2684145 · Received August 7, 2012

    Report

    Report Number
    3004209178-2012-06542
    Event Type
    Injury
    Date Received
    August 7, 2012
    Report Date
    July 10, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3889-28 LOT# V933650 SERIAL# IMPLANTED: 2012 (B)(6), EXPLANTED: PRODUCT TYPE LEAD; PRODUCT ID, 3037 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS EXPERIENCING A POST-OPERATIVE WOUND INFECTION. IT WAS NOTED THE DEVICE MAY HAVE TO BE EXPLANTED. THE PATIENT HAD ALSO FELT NO STIMULATION SENSATION TWO DAYS AFTER IMPLANT BUT 10 DAYS LATER REPORTED NO CONCERNS WITH DEVICE OR THERAPY. THE PATIENT HAD DIFFICULTIES USING THE DEVICE. THE DEVICE WAS REPROGRAMMED ON (B)(6) 2012. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE WAS EXPLANTED IN (B)(6) 2012 DUE TO INFECTION. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND A NEW DEVICE WAS NOT IMPLANTED. THE PATIENT OUTCOME WAS UNKNOWN. ANY ADDITIONAL INFORMATION RECEIVED WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MDT PUERTO RICO OPERATIONS CO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention