BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2250713 · Received September 12, 2011

    Report

    Report Number
    3004209178-2011-07753
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 26, 2011
    Report Date
    November 4, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD A URINARY TRACK INFECTION FOR ABOUT THREE WEEKS. THE INFECTION WAS APPARENTLY RESISTANT TO CIPROFLOXACIN AND MAYBE BACTRIM. IT WAS LATER REPORTED THAT THE PT EXPERIENCED A LACK OF THERAPEUTIC EFFECT WHILE STIMULATION WAS ON. THE PT STATED SHE WAS PUT ON A FEW ANTIBIOTICS TO CLEAR A URINARY TRACK INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A URINARY TRACT INFECTION (UTI) BECAUSE THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS NOT WORKING PROPERLY. THE PATIENT FELL WHICH CAUSED ONE OF THE ELECTRODES TO BREAK. THE INS WAS TURNED OFF 7-8 WEEKS AGO TO TREAT THE UTI, BUT THE PATIENT HAD NOT BEEN ABLE TO SEE THE HEALTH CARE PROVIDER AND KEPT GETTING MORE UTI¿S DUE TO URINARY ISSUES.

    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 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention PROGRAMMER: MODEL 3037, LOT # NJD091092N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3093, LOT #V295464