BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 3030719 · Received April 2, 2013

    Report

    Report Number
    3004209178-2013-04470
    Event Type
    Injury
    Date Received
    April 2, 2013
    Report Date
    March 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3037 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3 093-28 LOT# VA03Y4U, IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. THE PATIENT STATED, THE THERAPY WAS WORKING WHEN SHE FIRST GOT THE IMPLANT BUT SHE DID NOT THINK THE DEVICE WAS WORKING AT THE TIME OF REPORT. IT WAS REPORTED, THE PATIENT WAS HAVING FREQUENCY SYMPTOMS WHICH HAD BEEN GETTING WORSE IN THE MONTH PRIOR TO REPORT. THE PATIENT ALSO STATED, SHE HAD OTHER HEALTH ISSUES THAT MADE IT DIFFICULT TO TELL HOW HER THERAPY WAS WORKING. REPORTEDLY, THE PATIENT HAD CONTINUAL BLADDER INFECTIONS FOR THE YEAR PRIOR TO REPORT DUE TO BOWEL LEAKAGE. THE PATIENT'S HEALTHCARE PROVIDER PRESCRIBED TOPICAL CREAM TO FIGHT THE INFECTION BUT IT WAS REPORTED, THE CREAM WAS "NOT STRONG ENOUGH." THE PATIENT WAS ALSO PRESCRIBED ORAL MEDICATIONS FOR A YEAST INFECTION AND CLINDAMYCIN TO FIGHT INFECTION BUT NOTHING HAD HELPED. IT WAS REPORTED, THE PATIENT WAS SORE FROM THE INFECTIONS, COULDN'T SLEEP, AND WAS MISERABLE. IT WAS ALSO REPORTED THAT THE PATIENT MADE ADJUSTMENTS TO THE DEVICE BUT COULDN'T REMEMBER ALL OF THE ADJUSTMENTS. THE PATIENT STATED, SHE TRIED TWO OTHER PROGRAMS BUT DID NOT LIKE THEM. AT THE TIME OF REPORT, THE PATIENT WAS SET ON PROGRAM 2 AT 0.9 AMPS. THE PATIENT REPORTEDLY ADJUSTED THE STIMULATION UP TO 1.0 AMP AND STATED SHE COULD FEEL THE STIMULATION AND IT WAS COMFORTABLE. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    134014 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention