BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERSTIM II

    MDR report key: 3915648 · Received July 7, 2014

    Report

    Report Number
    3004209178-2014-12576
    Event Type
    Malfunction
    Date Received
    July 7, 2014
    Date of Event
    June 11, 2014
    Report Date
    June 11, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    EZW
    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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    FINAL DEVICE ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) REVEALED THE FOLLOWING: A KNOWN GOOD LEAD WAS INSERTED INTO THE CONNECTOR BLOCK AND THE SETSCREW WAS TIGHTENED. FORCE WAS APPLIED TO THE LEAD AND IT DID NOT COME LOOSE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3093-28, LOT# VA0K1B1, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD; PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE SET SCREW OF THE DEVICE WOULD NOT TIGHTEN SO A DIFFERENT DEVICE WAS USED AND EVERYTHING WAS FINE. THE PATIENT RECOVERED WITHOUT SEQUELA.

    Description of Event or Problem · 1

    IT WAS REPORTED ALL ELECTRODE IMPEDANCES WERE GREATER THAN 4000 OHMS EVEN AFTER CHANGING THE DEFAULT IMPEDANCE TEST PARAMETERS. IT WAS STATED THE LEAD WAS LOOSE INSIDE THE CONNECTOR HEADER BLOCK. REPORTEDLY, THE HEALTHCARE PROVIDER NOTED THEY HEARD THE CLICKS WHEN THEY ATTEMPTED TO TORQUE DOWN. IT WAS LATER REPORTED THE IMPEDANCES MEASUREMENTS WERE GREATER THAN 4000 OHMS ON ALL PAIRINGS. IT WAS STATED THEY WERE INSTRUCTED TO USE A DIFFERENT IMPLANTABLE NEUROSTIMULATOR (INS) AND THE ONE THEY INITIALLY USED WAS THOUGHT TO HAVE A FAULTY SET SCREW. IT WAS NOTED THE CAUSE OF THE IMPEDANCE ISSUE WAS DETERMINED AND NO LEAD FRACTURES WERE NOTED. IT WAS STATED THAT EVERYTHING WAS FINE AFTER THEY USED A DIFFERENT INS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393168 INTERSTIM II STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE EZW MEDTRONIC PUERTO RICO OPERATIONS CO. 3058

    Patients

    Seq Age Sex Outcome Treatment
    1 00084 YR