BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSIGNIA

    MDR report key: 2052681 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05307
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, DETAILED ANALYSIS REVEALED COMPROMISED HEADER BONDING. INSUFFICIENT MEDICAL ADHESIVE BONDING BETWEEN THE HEADER AND DEVICE CASE WAS FOUND. BOSTON SCIENTIFIC HAS IMPLEMENTED SUCCESSFUL CORRECTIVE ACTION FOR THIS ISSUE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PHYSICIAN ELECTIVELY EXPLANTED THIS DEVICE DUE TO NORMAL BATTERY DEPLETION, AS THE DEVICE HAD BEEN AT AN ESTIMATED REMAINING LONGEVITY OF ABOUT A YEAR FOR ONE YEAR AND HE FELT ELECTIVE REPLACEMENT STATUS WAS IMMINENT. DURING THE DEVICE REPLACEMENT PROCEDURE THE HEADER SNAPPED OFF THE DEVICE. IT WAS REPORTED THAT THE PHYSICIAN WAS ONLY USING HIS FINGERS TO REMOVE THE DEVICE AND DID NOT USE MUCH FORCE. THE PATIENT HAD AN UNDERLYING RHYTHM AROUND 40 BEATS PER MINUTE (BPM). A NEW DEVICE WAS SUCCESSFULLY IMPLANTED AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSIGNIA IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND 1297

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR (B)(4)| (B)(4)| 1297