BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 3904869 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-12538
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    April 30, 2014
    Report Date
    April 30, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED MYOPOTENTIAL OVERSENSING POST IMPLANT. NOISE WAS ABLE TO BE CREATED WITH ARM MOVEMENTS. ADDITIONALLY, OUT OF RANGE PACE IMPEDANCE MEASUREMENTS WERE EXHIBITED AT GREATER THAN 2,000 OHMS. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE AND THE LEAD WAS MANIPULATED AND TESTED. NORMAL IMPEDANCE MEASUREMENTS WERE OBSERVED. DURING LEAD INSPECTION THE PHYSICIAN FOUND THAT THE ATRIAL LEAD WAS KINKED JUST BEHIND THE WHITE SEAL THEREFORE, ADDITIONAL MANIPULATIONS WERE PERFORMED WHICH RESULTED IN NORMAL IMPEDANCE AND SENSING MEASUREMENTS. FINAL CHECK WAS THEN COMPLETED AND NO FURTHER COMPLICATIONS WERE REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN-SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    384131 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R J277| 4457| 7741