BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGEVITY

    MDR report key: 4132374 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-14669
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 11, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS PRODUCT HAS BEEN RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON ITS COMPLETION.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION OF THE LEAD FOUND THAT THE HELIX MECHANISM WAS RETRACTED AND DRIED BLOOD WAS NOTED IN THE HELIX HOUSING AND NECK REGION. AFTER INITIAL SONIC CLEANING TO REMOVE THE DRIED BODY FLUID, THE HELIX MECHANISM WOULD NOT EXTEND IN THE RECOMMENDED NUMBER OF TURNS. THE LEAD TIP HOUSING WAS REMOVED AND THE LEAD WAS AGAIN PLACED IN THE SONIC CLEANER. AFTERWARD, THE TIP WAS REPLACED AND THE HELIX WAS ABLE TO EXTEND AND RETRACT BUT DEPLOYMENT/RETRACTION WAS NOTED TO BE SLOW AND INTERMITTENTLY STICKY. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THAT BODY FLUID INSIDE THE HELIX HOUSING IN CONJUNCTION WITH LEAD DESIGN CHARACTERISTICS AND PROCEDURAL/IMPLANT FACTORS CAUSED THE IRREGULARITY IN HELIX FUNCTION. THE REPORTED OBSERVATION OF DISLODGEMENT COULD NOT BE CONFIRMED BY LABORATORY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISLODGED A SHORT TIME AFTER IMPLANT AS DISCOVERED DURING INTERROGATION AT FOLLOW-UP. REPOSITIONING WAS ATTEMPTED BUT NOT POSSIBLE AS THE HELIX COULD NO LONGER BE RETRACTED AND EXTENDED. THOUGH SATISFACTORY MEASUREMENTS WERE OBTAINED, IT WAS NOTED THAT IT TOOK SEVERAL ATTEMPTS AT IMPLANT TO FIND AN ACCEPTABLE ATRIAL POSITION. UPON REVISION, THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612724 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 7741| 7732| J277