BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2850347 · Received November 29, 2012

    Report

    Report Number
    3004209178-2012-10904
    Event Type
    Injury
    Date Received
    November 29, 2012
    Report Date
    November 1, 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
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3093-28, LOT # V017354, IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE PROGRAMMER.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AND STARTED PEEING THE NIGHT BEFORE THE REPORT. THE PATIENT WAS PEEING DURING THE NIGHT AND HAD DIFFICULTY GETTING TO THE BATHROOM IN TIME. THE PATIENT STATED THIS HAD NOT "HAPPENED IN YEARS" AND THERE WAS NO STIMULATION SENSATION. THE PATIENT STATED THAT SHE INITIALLY FELT STIMULATION, BUT SHE BECAME "USED" TO THE SENSATION AND DID NOT NOTICE IT ANYMORE. THE PATIENT DID NOT FEEL ANYTHING AT THE TIME OF THE REPORT AND IT HAD BEEN THAT WAY FOR "A WHILE." IT WAS ALSO REPORTED THAT AT THE TIME OF THE REPORT, THE PATIENT WAS BEING TREATED FOR A URINARY TRACT INFECTION (UTI) AND THAT SHE GOT KIDNEY INFECTIONS "FREQUENTLY" BECAUSE SHE WAS DIABETIC. THE PATIENT ALSO STATED SHE HAD A GASTRIC BYPASS SURGERY AND HAD LOST ABOUT (B)(6). AFTER THE PATIENT GOT HER PROGRAMMER WORKING, SHE WAS ABLE TO CONFIRM THAT THE DEVICE WAS TURNED ON AND RAISED THE STIMULATION TO 1.05 VOLTS. THE PATIENT FELT THE STIMULATION AND IT WAS COMFORTABLE. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 REPORTED THAT THE HEALTH CARE PROVIDER (HCP) HAD NO KNOWLEDGE OF THE SITUATION AS THE PATIENT HAD NOT BEEN IN THE OFFICE IN "MORE THAN FOUR YEARS." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY. THE PATIENT RECEIVED ASSISTANCE FROM HER HEALTHCARE PROVIDER OR MEDTRONIC REPRESENTATIVE. THEY WERE ABLE TO HELP AND HER CONCERNS WERE RESOLVED.

    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