BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTERSTIM II

    MDR report key: 7003419 · Received November 6, 2017

    Report

    Report Number
    3004209178-2017-23210
    Event Type
    Injury
    Date Received
    November 6, 2017
    Date of Event
    October 11, 2017
    Report Date
    March 2, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE INS, MODEL 3058, SERIAL NO. (B)(4), DETERMINED THAT THE SETSCREW WAS BACKED OUT BEYOND THE POINT OF BEING ABLE TO ENGAGE WITH THE CONNECTOR BLOCK. DUE TO THE REPORTED COMPLAINT, AN IMPEDANCE TEST WAS PERFORMED IN 0.9% SALINE SOLUTION AND GOOD IMPEDANCES WERE OBSERVED USING AN N'VISION CLINICIAN PROGRAMMER. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON THE ELECTRODE PAIRS THE INS HAD WHEN IT WAS RECEIVED. A LAB FUNCTIONAL TEST DETERMINED THERE WAS GOOD STABLE OUTPUT ON ALL ELECTRODE PAIRS REFERENCED TO THE ONE ELECT. ANALYSIS DETERMINED THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN. ANALYSIS DETERMINED THE TELEMETRY WAS ACCEPTABLE. 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 RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) VIA A MANUFACTURER REPRESENTATIVE REPORTED A CONSUMER HAD A RETURN OF SYMPTOMS. NO ENVIRONMENTAL FACTORS WERE NOTED TO HAVE CONTRIBUTED TO THE EVENT. TROUBLESHOOTING/ACTIONS/INTERVENTIONS WERE NOTED AS FOLLOWS: POSE OF A DEFINITIVE IPG INEFFECTIVE (POSE ON (B)(6)): REVISION SURGERY TO TRY TO RECONNECT LEAD/ICD. IN PER-OP: IMPOSSIBLE TO CONNECT: CHANGE OF THE ICD BECAUSE ICD IMPLANTED ON (B)(6) WAS DEFECTIVE. THE LEAD HAS NOT BEEN CHANGED AND HAS BEEN CONNECTED TO THE NEW ICD WITHOUT ISSUE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE DEVICE SETTINGS AS FOLLOWS: 0.6 V, 210 US, 14 HZ, C+0-, WITH CYCLING OFF. DATA SHOWED THE BATTERY RESULTS AS OK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CLARIFIED THAT THE ¿ICD¿ WAS THE IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS NOTED THAT THERE WAS NOT A DISCONNECTION OF THE LEAD/INS, RATHER THERE WERE HIGH IMPEDANCES UP TO 4000 OHMS, SO THE DOCTOR DECIDED TO TEST AND RECONNECT THE SYSTEM IN THE OR. THE TINED LEAD WAS GOOD (CHECKED DURING THE PROCEDURE), BUT IT WAS IMPOSSIBLE TO RECONNECT THE SYSTEM. SO, THE DOCTOR DECIDED TO CHANGE THE INS FOR A NEW ONE. IT WAS POSSIBLE TO CONNECT AND THE IMPEDANCE (CHECKED DURING THE PROCEDURE) WAS GOOD (LESS THAN 4000 OHMS).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782418 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention