BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 2920072 · Received January 17, 2013

    Report

    Report Number
    3004209178-2013-00702
    Event Type
    Malfunction
    Date Received
    January 17, 2013
    Report Date
    December 28, 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
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28, LOT# V842736, 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 THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT AND A RETURN OF SYMPTOMS FOLLOWING A FALL, WHICH CAUSED HER TO GO TO THE BATHROOM "REPEATEDLY." IT WAS INDICATED THAT THE PATIENT FELL IN (B)(6), PRIOR TO WHICH THE PATIENT'S SYMPTOMS WERE MANAGED WELL, BUT THE PATIENT DID NOT FOLLOW-UP WITH HER HEALTHCARE PROVIDER (HCP) AFTER THE FALL. THE REPORTER STATED THAT THE PATIENT WAS HOSPITALIZED IN OCTOBER FOR A "NON-RELATED ISSUE." AT THE TIME OF THE REPORT, THE PATIENT WAS SET ON PROGRAM 3 AT 6.5V WHICH USED TO COVER HER SYMPTOMS AND SHE USED TO FEEL. STIMULATION WAS SWITCHED TO PROGRAM 4, BUT THE PATIENT DID NOT FEEL STIMULATION EVEN WHEN IT WAS ADJUSTED ALL THE WAY TO THE MAXIMUM LEVEL. THE PATIENT WAS ABLE TO FEEL STIMULATION WHEN IT WAS SWITCHED TO PROGRAM 1 AT 6.1V. IT WAS NOTED TO BE STRONG BUT COMFORTABLE. THE REPORTER INDICATED THAT STIMULATION WOULD BE LEFT AT THAT SETTING AND SYMPTOMS WOULD BE TRACKED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS STILL HAVING CONCERNS WITH THEIR DEVICE OR THERAPY, BUT HAD NOT SOUGHT FURTHER HELP. NO FURTHER INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25563 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058

    Patients

    Seq Age Sex Outcome Treatment
    1