BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 7135532 · Received December 20, 2017

    Report

    Report Number
    3004209178-2017-26394
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    December 19, 2017
    Report Date
    February 12, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    UDI-DI
    00613994913654
    PMA / PMN Number
    P970004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IPG 3058 INTERSTIM LL ((B)(4)) FOUND THE IMPLANTABLE NEUROSTIMULATOR (INS) PASSED FUNCTIONAL TESTING, BUT IT WAS NOTICED THAT THE SET-SCREW WAS BACKED OUT TOO FAR. AS A RESULT OF THE REPORTED EVENT, AN IMPEDANCE TEST WAS PERFORMED AND GOOD IMPEDANCES WERE OBSERVED. A LAB FUNCTIONAL TEST WAS ALSO PERFORMED AND GOOD STABLE OUTPUT ON THE ELECTRODE PAIRS THE INS HAD WAS OBSERVED AS WELL. THERE WERE NO ISSUES WHEN PRESSING ON THE INS CAN AND 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

    NO NEW INFORMATION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) WHO SAID THE CAUSE OF THE HIGH IMPEDANCES WAS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    NO NEW INFORMATION.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS BEING IMPLANTED WITH A NEUROSTIMULATOR. IT WAS REPORTED THAT THE REP WAS IN THE OPERATING ROOM (OR) IMPLANTING A STAGE 2. THE PATIENT HAD A MOTOR RESPONSE DURING STAGE 1, BUT WAS UNDER ANESTHESIA AT THE TIME OF THE REPORT AND THEY WERE GETTING ELECTRODE IMPEDANCE TESTING DONE. AT 2 VOLTS (V) AND 360 PULSE WIDTH (PW), C0, 01, 02, AND 03 WERE SHOWING GREATER THAN 4,000 OHMS. THE PHYSICIAN DECIDED TO SWITCH THE IMPLANTABLE PULSE GENERATOR (IPG) OUT WITH A NEW IPG, WHERE ALL IMPEDANCES WERE NORMAL. THERE WERE NO SYMPTOMS OR FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    915448 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058 00613994913654

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR