BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 4132228 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14498
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    June 24, 2014
    Report Date
    July 23, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION CONFIRMED THE HELIX WAS FULLY EXTENDED WHEN RETURNED. ANALYSIS FOUND THAT THE CATHODE COIL (INNER COIL) WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. BASED ON THE NECKING DOWN OF THE COIL, THIS IS MOST LIKELY THE RESULT OF TRYING TO EXTEND THE HELIX.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT OF THE RIGHT ATRIAL (RA) LEAD, THE CONNECTOR TOOL WAS TURNED ONE TURN PER SECOND. THE PHYSICIAN ELECTED TO REPOSITION THE LEAD, HOWEVER, THE HELIX DID NOT RETRACT AFTER 8 TO 12 TURNS. THIS LEAD WAS REMOVED AND RETURNED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612116 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 4096| J063| 7742| 7741