BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 2854640 · Received December 3, 2012

    Report

    Report Number
    3004209178-2012-11065
    Event Type
    Injury
    Date Received
    December 3, 2012
    Report Date
    November 8, 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
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 3093-28 LOT# V833301, IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT "COULD NOT STOP" URINATING. THE PATIENT URINATED THREE TO FOUR TIMES A NIGHT AND "FREQUENTLY" DURING THE DAY. THE PATIENT HAD HAD URINARY TRACT INFECTIONS (UTI) "OFF AND ON" SINCE THE IMPLANT. THE PATIENT BEGAN ANTIBIOTIC TREATMENT ON (B)(6) 2012 FOR ANOTHER UTI WHICH CAUSED HER TO HAVE URINARY FREQUENCY. THE WEEK PRIOR TO THE REPORT, THE PATIENT SAW HER HEALTH CARE PROVIDER (HCP) AND DID NOT HAVE A UTI AT THAT TIME, BUT CONTINUED TO EXPERIENCE THE URINARY FREQUENCY. THE PATIENT STATED HER URINARY FREQUENCY SEEMED TO "GET BETTER AND THEN WORSE" AND WANTED TO ADJUST HER STIMULATION. PROGRAM FOUR GAVE THE PATIENT BOWEL ISSUES AND CONSTIPATION, SO SHE USED PROGRAM TWO. THE PATIENT INCREASED STIMULATION FROM 1.10 VOLTS TO 1.15 VOLTS AND WANTED TO SEE IF THAT HELPED HER SYMPTOMS. THE PATIENT WAS ABLE TO FEEL STIMULATION IN HER PELVIC FLOOR AREA, BUT THE SENSATION WOULD "COME AND GO." THE PATIENT WAS TO SCHEDULE A VISIT WITH HER HCP IF THE NEW SETTINGS DID NOT HELP. ADDITIONAL INFORMATION WAS 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 NO LONGER HAD CONCERNS ABOUT THEIR DEVICE OR THERAPY. NO FURTHER INFORMATION WAS PROVIDED.

    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