BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2851235 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10930
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Report Date
    November 2, 2012
    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
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT# V979271, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT LOST THERAPEUTIC EFFECT. PATIENT HAD THE IMPLANTABLE NEUROSTIMULATOR (INS) FOR FOUR MONTH AND THE DAY OF THIS REPORT WAS GETTING LEAKAGE. PATIENT 'WET HER PANTS AND (B)(6).' IT WAS WHAT PATIENT USED TO DO BEFORE GETTING DEVICE. PATIENT TURNED ON STIMULATION AND CHANGED PROGRAMS. PATIENT WAS TAKING KEFLEX AND GENTAMICIN FOR LEG. PATIENT HAD A BASAL CELL CARCINOMA REMOVED. PATIENT WAS FEELING PRESSURE 'LIKE' URINARY TRACT INFECTION (UTI) BUT WITHOUT THE FOUL SMELL THAT NORMALLY HAPPENS WHEN HAVING A UTI. INCISION SITE WAS BURNING AND HURTS. SYMPTOMS STARTED THE DAY BEFORE THIS REPORT, BUT PATIENT WAS 'OK' THE NIGHT BEFORE THIS REPORT AND SYMPTOMS RETURNED THE MORNING OF THIS REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention