BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXIMO II VR

    MDR report key: 1922887 · Received December 13, 2010

    Report

    Report Number
    6000144-2010-06007
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    September 23, 2010
    Manufacturer
    MEDTRONIC MED REL, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016/S114
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE DEVICE HAD A ROUNDED SET SCREW SOCKET.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT PROCEDURE THAT UPON INSERTING THE HIGH VOLTAGE LEAD INTO THE CONNECTOR PIN AND ATTEMPTING TO SET THE SET SCREW THAT THE PHYSICIAN COMMENTED THAT SCREW NEVER SEEMED TO TIGHTEN. HE CONTINUED TO TURN THE SCREW CLOCKWISE WITH NO PERCEIVED TIGHTENING. NO AUDIBLE TIGHTENING WAS EVER NOTED DURING THE PROCEDURE. LEAD IMPEDANCES WERE TAKEN CONTINUALLY THROUGHOUT PROCESS. NO IMPEDANCE LESS THAN 200OHMS WAS EVER NOTED. HE WAS INSTRUCTED TO REMOVE THE PIN AND TURN THE SCREW COUNTER-CLOCKWISE TO BACK THE SCREW OUT OF THE HEADER, REINSERT THE PIN AND ATTEMPT TO TURN CLOCKWISE. NO SUCCESS WAS NOTED ON THE FIRST PASS. HE ATTEMPTED THE AFOREMENTIONED STEPS A SECOND TIME, WITHOUT SUCCESS. A NEW WRENCH KIT WAS ATTEMPTED WITHOUT SUCCESS AND A SERVICE KIT WAS USED TO ATTEMPT TO INTRODUCE A NEW SET SCREW, BUT THAT ALSO WAS NOT SUCCESSFUL. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAXIMO II VR IMPLANTABLE PACEMAKER/CARDIO/DEFIB LWS MEDTRONIC MED REL, INC. D284VRC ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other