BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXUS

    MDR report key: 4131516 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13858
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    July 1, 2014
    Report Date
    August 25, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RETURN AND ANALYSIS THIS INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE HEADER WAS RETURNED WITH NO DEVICE. A PIECE OF THE LEAD WAS ATTACHED TO THE RIGHT VENTRICULAR PORT. AS RECEIVED IT WAS NOTED THAT THE HEADER HAD BEEN CUT BEHIND THE DISTAL TERMINAL BLOCKS. VISUAL INSPECTION NOTED THAT THE ATRIAL RING TERMINAL BLOCK WAS MISSING FROM THE HEADER, AND BOTH VENTRICULAR TERMINAL BLOCKS HAD BEEN PUSHED OUT OF THE HEADER. THE BACK OF THE HEADER WHERE THE RV TIP TERMINAL BLOCK IS LOCATED WAS FURTHER CUT AWAY IN ORDER TO SEE WITHIN THE TERMINAL BLOCK. THE TIP OF THE LEAD COULD BE SEEN IN THE TERMINAL BLOCK. PORTIONS OF THE HEADER WERE CUT AWAY IN ORDER TO REMOVE THE LEAD OUT OF THE HEADER. FINAL INSPECTION NOTED THAT THE RIGHT VENTRICULAR TIP AND RING SETSCREW WAS COMPLETELY RETRACTED UP AGAINST ITS CAPTURE WASHER, AND THE RIGHT VENTRICULAR RING SETSCREW HAD A PIECE OF THE HEX WRENCH TIP BROKEN OFF INSIDE THE HEX SLOT. DUE TO THE DAMAGE TO THE HEADER IT WAS NOT POSSIBLE TO TROUBLESHOOT THE REASON THE LEADS WERE STUCK IN THE HEADER.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECIEVED NOTED THAT THE DEVICE WAS RETURNED. UPON ANALYSIS THIS INVESTIGAITON WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A DEVICE REPLACEMENT THE RIGHT VENTRICULAR LEAD WAS ATTEMPTED TO BE REMOVED, HOWEVER, IT WAS NOT POSSIBLE TO REMOVE THE LEAD OUT OF THE DEVICE HEADER PORT. THE SETSCREW OF THIS DEVICE WAS LOOSENED AND PULLED WHICH RESULTED IN THE INSULATION NEAR THE DISTAL ELECTRODE TO STRETCH AND INNER COIL TO BE EXPOSED. THE HEADER WAS BROKEN BUT THE LEAD WAS STILL NOT REMOVED. A NEW SYSTEM WAS IMPLANTED ON THE OPPOSITE SIDE. THE RIGHT ATRIAL LEAD WAS SURGICALLY ABANDONED WHILE THE RIGHT VENTRICULAR LEAD WAS SEVERED AND REMAINED IN THE PATIENT. THE DEVICE WAS EXPLANTED AND WILL BE RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610631 NEXUS IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND 1468

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR 406-04| 430-07| MISMATCH| 1468| 284-05| 4456