BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 6883307 · Received September 21, 2017

    Report

    Report Number
    3004209178-2017-19818
    Event Type
    Malfunction
    Date Received
    September 21, 2017
    Date of Event
    January 1, 2017
    Report Date
    September 21, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT: DATE IS APPROXIMATE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR FOR GASTROINTESTINAL/PELVIC FLOOR. PATIENT REPORTED THAT THE THERAPY WAS WORKING GREAT BUT NOW IT WAS NOT WORKING AS WELL ANYMORE AND SHE HAD GONE BACK TO HER HEALTHCARE PROVIDER (HCP) AND THE PROGRAM WAS CHANGED BUT THE THERAPY STILL WASN'T WORKING AS SO GOOD. PATIENT STATED THAT SHE WENT BACK TO SEE THE HCP LAST WEEK BUT THE HCP TOLD HER TO STAY ON THAT PROGRAM TO TRY IT OUT A LITTLE LONGER. PATIENT STATED THAT SHE HAD BEEN INCREASING STIMULATION. PATIENT STATED THAT SHE WAS GOING BACK TO SEE HER HCP NEXT MONTH. PATIENT STATED THAT THE THERAPY WAS WORKING GREAT FOR 6 MONTHS THEN WASN'T WORKING AS WELL ANYMORE. ADDITIONAL INFORMATION WAS RECEIVED, IT WAS REPORTED THAT THE PATIENT WAS HAVING A MAGNETIC RESONANCE ANGIOGRAM (MRA) AND NEEDED TO SHUT THEIR DEVICE OFF. ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE PATIENT HAD INCREASED AMPLITUDE, BUT ONLY FELT STIMULATION FOR A FEW MINUTES BEFORE IT WENT AWAY. CALLER WAS REPORTING HIGH IMPEDANCES ON ONE PAIR. CALLER REPORTED C0 1205, C1 1049, C2 658, C3 584; 01 >4000, 02 2026, 03 1909, 12 1415, 13 1549, 23 1016. PATIENT WAS ON PROGRAM 1 UNTIL (B)(6) 2017, WHEN IT STOPPED WORKING AND THEY SWITCHED TO PROGRAM 2, WHICH NEVER WORKED FOR THE PATIENT. PROGRAM 2 WAS PROGRAMMED TO USE 3+ 0- AT 2.6 V. THE CALLER SWITCHED TO PROGRAM 1 DURING THE CALL AND THE PATIENT WAS FEELING DISCOMFORT FROM THIS PROGRAM AT 2.4 V. CALLER DECREASED THE AMPLITUDE TO 1 V AND THE PATIENT CONTINUED TO FEEL STIMULATION. PROGRAM 3 WAS SET TO +3 -1, PROGRAM 4 WAS SET TO -2 +0. THE CALLER INDICATED THEY PLANNED TO LEAVE THE PATIENT ON PROGRAM 1 FOR THE TIME BEING AND WOULD RE-EVALUATE AFTER A PERIOD OF TIME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED BECAUSE OF THIS EVENT IN THE EVENT DESCRIPTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664779 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR