BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 3905596 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12115
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    May 16, 2014
    Report Date
    July 7, 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. X-RAY CONFIRMED THE CATHODE CONDUCTOR COIL WAS FRACTURED AT THE DISTAL END OF THE TERMINAL PIN. THE DISTAL SIDE OF THE FRACTURE SHOWED THAT THE CONDUCTOR COIL WAS BIRDS NESTED AT THE FRACTURE SITE. THE BIRDS NESTED COIL WOULD INDICATE A FRACTURE WHILE ATTEMPTING TO RETRACT THE HELIX.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED NORMAL MEASUREMENTS WITH THE PACING SYSTEM ANALYZER (PSA). WHEN CONNECTED TO THE DEVICE, THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS WITH HIGH THRESHOLD MEASUREMENTS. TROUBLESHOOTING WAS PERFORMED AND CONCLUDED THE CONNECTION WAS VERIFIED TO BE APPROPRIATE. THE LEAD AND DEVICE WERE DISCONNECTED, THEN CONNECTED SEVEN TIMES WITH THE SAME RESULTS. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384455 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 7741