BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 14073641 · Received April 11, 2022

    Report

    Report Number
    3004209178-2022-04503
    Event Type
    Malfunction
    Date Received
    April 11, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 20, 2022
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

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

    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.

    Description of Event or Problem · 0

    INFORMATION WAS RECEIVED FROM A PATIENT(PT) WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/PELVIC FLOOR THERAPY AND FE CAL INCONTINENCE. IT WAS REPORTED THAT THE PT REPORTED THEY SAW A POR MESSAGE YESTERDAY WHILE CONNECTING TO THEIR INS TO INCREASE THERAPY STRENGTH. PT WAS REDIRECTED TO HCP TO CLEAR.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM PATIENT. THEY REPORTED THAT PROGRAMMER WON'T ALLOW THEM TO DO ANYTHING WITH THEIR IMPLANT. DURING CALL, PATIENT CONNECT TO THE IMPLANT AND THEY MENTIONED THEY WERE SEEING POOR COMMUNICATION. PATIENT ONLY USES PATIENT PROGRAMMER WITHOUT ANTENNA. PATIENT STATES THIS WAS NOT THE NORMAL SCREEN THEY HAVE BEEN SEEING THAT HAS BEEN GIVING THEM ISSUES. PATIENT STATES NORMALLY THEY SEE POR. THEY STATED THEY TRIED CONTACTING HEALTHCARE PROFESSIONAL (HCP) OFFICE BUT THEY STATED THEY DO NOT MANAGE THE INTERSTIM DEVICES SO THEY'RE UNABLE TO ASSIST THE PATIENT. IT WAS REVIEWED WITH PATIENT POSSIBLE MEANINGS OF POR AND IS SENDING OUT LISTINGS OF PHYSICIANS THAT MAY HELP TO CLEAR THE POR MESSAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2445094 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female