BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4131653 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13767
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    May 23, 2014
    Report Date
    July 14, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS REVEALED THAT THE CATHODE COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. BASED ON THE PRESENTATION OF THE COIL, THE DAMAGE WAS LIKELY THE RESULT OF TRYING TO EXTEND THE HELIX. THE HELIX WAS FULLY EXTENDED UPON RETURN. THE DISLODGEMENT WAS UNABLE TO BE CONFIRMED DURING ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS UNABLE TO BE SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT THE LEAD DISLODGED AND THAT THE PHYSICIAN WAS UNABLE TO SUCCESSFULLY EXTEND THE HELIX MECHANISM. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS REPORT IS BEING FILED DUE TO LABORATORY FINDINGS.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612106 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 J067| 7741| MISMATCH