BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 6327544 · Received February 13, 2017

    Report

    Report Number
    3004209178-2017-03771
    Event Type
    Injury
    Date Received
    February 13, 2017
    Date of Event
    January 26, 2017
    Report Date
    February 17, 2017
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    CALLER REPORTED THAT THEIR SYMPTOMS WERE NOT WORSE BUT THEY WERE SEEING A '5' ON HER PROGRAMMER. UNCLEAR IF 5 WAS AMPLITUDE OR SOMETHING ELSE. PATIENT REPORTED THE POOR COMMUNICATION AS SWELLING AND BANDAGES WERE STILL PRESENT. PATIENT REPORTED UTI-LIKE SYMPTOMS, WHICH BEGAN ON (B)(6) 2017. PATIENT JUST STARTED NOTICING SYMPTOMS AND HAD NOT YET BEEN ACTUALLY DIAGNOSED WITH UTI. EXPLAINED THAT IF A PATIENT DID HAVE AN ACTUAL UTI, THAT CAN POTENTIALLY AFFECT THE RESULTS OF THE THERAPY SO IT WAS RECOMMENDED TO GO TO HCP TO BE TESTED TO EITHER CONFIRM OR RULE OUT UTI. PATIENT WAS IMPLANTED FOR GASTROINTESTINAL/ PELVIC FLOOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) AND IT WAS REPORTED THAT THE PATIENT SAID SHE HAD FREQUENCY AND BURNING, NO FEVER IN OFFICE, DP PERFORMED AND THE PATIENT¿S URINE WAS CLEAR. THE HCP REPORTED THAT THE PATIENT¿S URINE WAS SENT OUT FOR UA WITH MICROSCOPIC AND CULTURE. THE HCP REPORTED THAT THE PATIENT WAS ADVISED TO DRINK PLENTY OF WATER AND COULD TAKE AZO OVER THE COUNTER. THE HCP REPORTED THAT THE URINE CULTURE WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108034 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other