BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM

    MDR report key: 12984941 · Received December 13, 2021

    Report

    Report Number
    3004209178-2021-18455
    Event Type
    Malfunction
    Date Received
    December 13, 2021
    Date of Event
    October 1, 2021
    Report Date
    January 19, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00763000203849
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM HCP. THEY REPORTED THAT PATIENT STARTED TAKING AZO FOR PAIN RELATED TO POSSIBLE UTI BUT URINE TESTED NEGATIVE. PATIENT WAS ALREADY TAKING AZO AT THE TIME OF URINE TESTING, AND NOT SPECIFIC HCP RECOMMENDATION. THE REPORT FROM PATIENT REGARDING PAIN IS THAT IT HAS RESOLVED. THE CAUSE OF THE PROGRAMS HAVING SWITCHED WITHOUT PATIENT'S KNOWLEDGE WAS UNKNOWN. THE PATIENT SPOKE WITH MANUFACTURER REPRESENTATIVE (REP) AND QUESTIONABLY RELATES TO PATIENT CONTROLLER. HCP WAS NOT AWARE OF PRIOR REPORTS OF THIS TYPE OF INCIDENT. WHEN SWITCHING PROGRAMS, THEY START AT 0V TO ABOVE, AND SHOULD NOT START WITH STIMULATION. THEY STATED THEY WOULD REQUEST INFORMATION FROM MANUFACTURER AS TO PRIOR REPORTS AND CONTRIBUTING FACTORS. THE STEPS TAKEN FOR RESOLUTION WAS PATIENT CONTACTED MANUFACTURER AND AND UPDATED PROGRAM AS OF (B)(6) 2021. PATIENT TRIED A NEW PROGRAM. IF THE PROBLEM PERSISTED, THEY WILL SET UP A VISIT IN THE OFFICE WITH THE MANUFACTURER REPRESENTATIVE (REP) AND HCP IF NEEDED.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIM AND GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT HAS TROUBLE WITH PROGRAMMING. PT REPORTS PROGRAMS SWITCH WITHOUT PT KNOWLEDGE STARTING IN OCTOBER. PT STATES EXPERIENCES PAIN SO INTENSE IT FEELS LIKE A UTERINE INFECTION. PT ALSO MENTIONED THE PAIN WAS INTENSE WHILE URINATING "IT WAS GOING INTO HAND". PT STATES CHECKED INS AFTER PAIN WAS FELT AND SAW SETTINGS HAD CHANGED TO PROGRAM A AT 1.9. PT REPORTS SWITCHED TO PROGRAM C. PT STATES WOKE UP THIS MORNING TO PAIN AND AFTER CHECKING INS SAW IT HAD SWITCHED TO PROGRAM B. PT REPORTS SWITCHED BACK TO PROGRAM C AT 0.4MA. AGENT WALKED PT THROUGH CONNECTING AND SAFELY DISCONNECTING FROM APP. PT CONFIRMED CURRENTLY FEELING COMFORTABLE STIMULATION. THE ISSUE WAS NOT RESOLVED THROUGH TROUBLESHOOTING. THE PATIENT WAS REDIRECTED TO THEIR HEALTHCARE PROVIDER TO FURTHER ADDRESS THE ISSUE. PT REPORTS SPOKE WITH HCP REGARDING ISSUE AND HCP STARTED PT ON AZO AND ADVIL. AGENT PROVIDED NAS NUMBER SO MDT REP CAN MEET PT AT NEXT HCP APPOINTMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1886166 INTERSTIM STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 97810 00763000203849

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female