BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8685530 · Received June 10, 2019

    Report

    Report Number
    3004209178-2019-11284
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 14, 2019
    Report Date
    June 11, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT: PATIENT CLARIFIES THE DEVICE IS SHUTTING OFF SINCE SHE CHECKS FOR THE LIGHTNING BOLT (UNDERSTOOD TO BE THE DEVICE ON ICON ON THE PATIENT PROGRAMMER.) NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT REP WAS NOT AWARE OF ANY PROBLEMS WITH THIS PATIENT. PATIENT KNOWS HOW TO USE THE PROGRAMMER AND UNDERSTANDS THE DEVICE. THE REP DO NOT REMEMBER HER CALLING WITH ANY PROBLEMS AND WAS NOT SURE WHY SHE IS HAVING PROBLEMS WITH THE DEVICE TURNING OFF. THE REP HAVE NO IDEA WHAT THE PATIENTS WEIGHT IS AND DO NOT KNOW IF THE PROVIDER KNOWS WHAT IS GOING ON.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WITH AN IMPLANTED NEUROSTIMULATOR (INS) FOR BOWEL DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL /PELVIC FLOOR THERAPY. IT WAS REPORTED THE DEVICE HAS BEEN SHUTTING DOWN FOR TWO WEEKS. PATIENT STATES SHE IS HAVING PROBLEMS WITH DEVICE FOR TWO WEEKS AND SPOKE TO A MANUFACTURER¿S REP WHO SAID TO KEEP ROTATING PROGRAMS. PATIENT STATES THE REP SAID TO TURN OFF FOR AN HOUR AND SET TO DIFFERENT PROGRAM AND TURN BACK ON. PATIENT STATES THE DEVICE IS NOT HELPING, AND WAS ADVISED TO FOLLOW UP WITH THEIR HEALTHCARE PROFESSIONAL (HCP). NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478435 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR