BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7241110 · Received February 5, 2018

    Report

    Report Number
    3004209178-2018-02056
    Event Type
    Injury
    Date Received
    February 5, 2018
    Report Date
    March 25, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    PMA / PMN Number
    P970004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS, MODEL 3058, SERIAL NO. (B)(4), FOUND BATTERY NORMAL END OF LIFE, TELEMETRY AND OUTPUT OKAY. THE INS WAS AT END OF SERVICE (EOS) AND FUNCTIONALITY COULD NOT BE TESTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, EXPLANTED: (B)(6) 2018, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    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 RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A CONSUMER¿S IMPLANTABLE NEUROSTIMULATOR (INS) WAS REPLACED DUE TO BATTERY DEPLETION AFTER ONE (1) YEAR. INTERVENTIONS/ACTIONS WERE NOTED AS THE CONSUMER GOT A NEW ELECTRODE AND A NEW TEST PHASE WAS BEING DONE BEFORE IMPLANTING ANOTHER INS. PROGRAMMING WAS NOTED AS AMPLITUDE 4.0 V, PULSE-WIDTH 450 US, AND FREQUENCY 50 HZ. THE ISSUE WAS NOTED AS RESOLVED. NO SYMPTOMS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED SYMPTOMS AS ¿THE THERAPY SUCCESS WAS GONE ANYMORE.¿ WITH RESPECT TO ANY TROUBLESHOOTING PER FORMED, IT WAS NOTED THAT WHEN THERE IS BATTERY DEPLETION, THERE IS NO TELEMETRY. A NEW LEAD WAS PLACED IN ANOTHER POSITION (S3) AND NOTED THE LEAD WAS ¿REPLACED ABOUT BETTER AMPLITUDE THRESHOLD.¿ IT WAS NOTED THAT THE LEAD BROKE DURING EXPLANT AND WOULD NOT BE RETURNED. INS DATA SHOWED THE FOLLOWING SETTINGS: 4 V, 420 US, 50 HZ, C+3-, WITH CYCLING OFF, AND BATTERY RESULTS = EOS (END OF SERVICE).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86070 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention