BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 6021316 · Received October 12, 2016

    Report

    Report Number
    2124215-2016-13062
    Event Type
    Malfunction
    Date Received
    October 12, 2016
    Date of Event
    July 14, 2016
    Report Date
    August 3, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED. RESISTANCE TESTING FOUND THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS CONFIRMED THAT THE INNER CONDUCTOR COIL HAD A BREAK NEAR THE TERMINAL PIN. BASED UPON THE CLINICAL OBSERVATIONS AND THE LABORATORY FINDINGS, WE BELIEVE THAT TORSIONAL OVERSTRESS DURING ATTEMPTS TO EXTEND/RETRACT THE HELIX CAUSED THE INNER CONDUCTOR COIL TO BREAK.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS ATTEMPTED AT IMPLANT, HOWEVER THE HELIX MECHANISM WOULD NOT EXTEND AFTER 30 ROTATIONS. A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    674417 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7740

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR 4076| 7740| 7741| L301