BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 8027501 · Received November 1, 2018

    Report

    Report Number
    3004209178-2018-24409
    Event Type
    Malfunction
    Date Received
    November 1, 2018
    Date of Event
    October 30, 2018
    Report Date
    February 12, 2019
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A CORRECTION WAS MADE TO THE DEVICE SERIAL NUMBER, THE SERIAL NUMBER INITIALLY REPORTED WAS INCORRECT. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. 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 IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES 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 REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT 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 MANUFACTURER REPRESENTATIVE. THEY REPORTED THAT THE IMPEDANCE WAS OFF, THEY NOTICED THERE WAS PRECIPITATION IN THE BATTERY, SO IT WAS ULTIMATELY REMOVED AND REPLACED. IT WAS FURTHER REPORTED THAT THE DEVICE HAD NOT BEEN USED BY THE PATIENT AND THERE WAS NO PATIENT INJURY AS A RESULT OF THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE RETURNED DEVICE WAS SUBJECTED TO A SERIES OF STANDARD TESTS THAT INCLUDE BUT IS NOT LIMITED TO VISUAL INSPECTION, OUTPUT AND TELEMETRY TESTING, AND FUNCTIONAL TESTING. THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING; HOWEVER, FOREIGN MATERIAL WAS OBSERVED IN THE IMPLANTABLE NEUROSTIMULATOR (INS) CONNECTOR PORT. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR. IT WAS REPORTED THAT THE INS WAS OPENED DURING THE PROCEDURE AND IT HAD CLEAR PRECIPITATION IN THE CLEAR AREA WHERE YOU WOULD MAKE THE LEAD CONNECTION. THEY REPORTED THEY KEPT GETTING BAD IMPEDANCE READINGS AND DETERMINED THEY WOULD TRY AN ALTERNATIVE BATTERY. IT WAS REPORTED THAT STORAGE CONDITIONS AT THE ACCOUNT OR WHERE IT HAD BEEN STORED PRIOR MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. THE MANUFACTURER REPRESENTATIVE WAS PRESENT AT THE SURGERY AND WAS ASSISTING SURGEON WITH THE IMPEDANCE CHECK WHEN REPLACING THE INS. MANUFACTURER REPRESENTATIVE'S TRUNK STOCK WAS USED INSTEAD OF STOCK PROVIDED BY THE ACCOUNT. IT WAS REPORTED THAT THE PATIENT WAS NOT AFFECTED BY THIS ISSUE AND IT WAS RESOLVED AT THE TIME OF THE REPORT. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868047 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR