BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2440931 · Received February 7, 2012

    Report

    Report Number
    3004209178-2012-00818
    Event Type
    Injury
    Date Received
    February 7, 2012
    Report Date
    May 23, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3889-28 LOT# V132957 IMPLANTED (B)(6) 2008 EXPLANTED UNK; PROGRAMMER MODEL 3037 SERIAL# (B)(4).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE PATIENT CONTINUED TO HAVE ISSUES, BUT SOUGHT HELP AS NEEDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR A WEEK DUE TO THE INFECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI). THE PATIENT HAD BEEN PLACED ON APPROXIMATELY FIVE ROUNDS OF ANTIBIOTICS BUT THE UTI WAS STILL PRESENT. THE PATIENT EXPERIENCED A BURNING SENSATION WHEN URINATING SINCE HER NEUROSTIMULATOR WAS REPLACED IN (B)(6) 2011. THE PATIENT WAS SCHEDULED TO MEET WITH HER PHYSICIAN. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION SHOWED THE PATIENT BELIEVED SHE WAS A RETAINING URINE. IT WAS STATED THAT "ALMOST EVERY MONTH" THE PATIENT'S DEVICE BATTERY WAS REPLACED IN (B)(6) 2011 "SHE HAS HAD A URINARY TRACT INFECTION, AND SHE HAS ONE NOW."

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO URINARY TRACT INFECTION.

    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 Hospitalization| R