BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 12476491 · Received September 15, 2021

    Report

    Report Number
    6000153-2021-00050
    Event Type
    Injury
    Date Received
    September 15, 2021
    Date of Event
    September 10, 2021
    Report Date
    October 12, 2021
    Manufacturer
    NEURO - VILLALBA
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 3093-33 LOT# V945720, IMPLANTED: (B)(6), PRODUCT TYPE LEAD PRODUCT ID 3093-33 LOT# V945720, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD 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 A MANUFACTURER REPRESENTATIVE (REP). THE REP REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. THERE WAS NO VISIBLE DAMAGE TO THE LEAD DURING BATTERY EXCHANGE, THERE WAS NO VISIBLE CONNECTION ISSUE OF THE LEAD WITH THE BATTERY. INTRA-OPERATIVE IMPEDANCE CHECK WAS PERFORMED AND MATCHED THE RESULTS OF THE PRE-OPERATIVE IMPEDANCE CHECK WHICH WAS >4000 OHMS ON ELECTRODE 1. THE IMPEDANCE TEST RESULTED IN THE SAME WITH A NEW INS. IT WAS REQUESTED BY THE PHYSICIAN TO PROGRAM AROUND ELECTRODE ONE TO RESOLVE THE ISSUE. THERE WOULD BE NO SURGICAL INTERVENTION AND THE DEVICE WAS NOT RETURNED.

    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 MULTIPLE SOURCES (MANUFACTURER REPRESENTATIVE, HEALTHCARE PROVIDER) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR GASTROINTESTINAL/ PELVIC FLOOR. IT WAS REPORTED THAT PATIENT PRESENTED FOR AN IPG REPLACEMENT ON (B)(6) 2021. PRIOR TO THE PROCEDURE, THE 8840 WAS USED TO TEST FOR IMPEDANCE AND TO TURN INTERSTIM IPG OFF. IMPEDANCE CHECK RESULTED IN IMPEDANCE OF >4000 OHMS IN ALL COMBINATIONS OF ELECTRODE 1. THIS WAS AN UNEXPECTED RESULT. PHYSICIAN MADE AWARE AND DECIDED TO PROCEED WITH IPG REPLACEMENT ONLY. REGARDING ANY ENVIRONMENTAL/EXTERNAL/PATIENT FACTORS THAT MAY HAVE LED OR CONTRIBUTED TO THE ISSUE, IT WAS NOTED THAT PATIENT DENIED HAVING ANY FALLS, AND THERE WERE NO KNOWN INFECTIONS. TROUBLESHOOTING DONE: IMPEDANCE TEST RUN AT 1.0V - RESULTS SHOWED >4,000 OHMS IN ALL COMBINATION OF ELECTRODE 1. IMPEDANCE TEST ATTEMPTED TO RUN AT 1.5V, BUT PATIENT WAS UNABLE TO TOLERATE SENSATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1374709 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW NEURO - VILLALBA 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention "SEE H10...."