BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7969254 · Received October 16, 2018

    Report

    Report Number
    3004209178-2018-23111
    Event Type
    Injury
    Date Received
    October 16, 2018
    Report Date
    January 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P080025
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BELOW ARE THE ANALYSIS FINDINGS AND TEST RESULTS: PRODUCT ID# 3058 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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3889-28 LOT# VA1GFDG, IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2018, PRODUCT TYPE LEAD. 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889-28, LOT #: (B)(4), IMPLANTED: (B)(6) 2017, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3889-28, SERIAL/LOT #: (B)(4), UBD: 23-APR-2021, UDI#: (B)(4). 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

    H3 - ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BY A MANUFACTURER REPRESENTATIVE (REP) FROM AN HEALTHCARE PROVIDER (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR FECAL INCONTINENCE AND GASTROINTESTINAL/PELVIC FLOOR WHO REPORTED THAT THE PATIENT WAS UNDERGOING A POCKET REVISION, BUT WHEN THE SURGEON OPENED THE POCKET THEY FOUND AN INFECTION AND AS A RESULT THE PATIENT'S INS AND LEAD WERE EXPLANTED. THE REASON FOR THE POCKET REVISION WAS PAIN AT THE POCKET SITE. PATIENT STATUS IS UNKNOWN AT THE TIME OF THIS REPORT AND NO DEVICE MALFUNCTIONS WERE REPORTED. THERE WERE NO FURTHER COMPLICATION REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE HEALTHCARE PROFESSIONAL REPORTING THAT THE INFECTION HAS RESOLVED, AND THERE WAS NO CURRENT INFECTION. NO FURTHER COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    NO NEW INFORMATION RECEIVED. DEVICE RECEIVED BACK

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810339 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R