BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 6266913 · Received January 20, 2017

    Report

    Report Number
    2124215-2016-21079
    Event Type
    Malfunction
    Date Received
    January 20, 2017
    Date of Event
    November 30, 2016
    Report Date
    December 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    UDI-DI
    00802526523489
    PMA / PMN Number
    P150012/S000
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, 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    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE HELIX WAS RETRACTED AND DRIED BLOOD/TISSUE WAS PRESENT AROUND THE HELIX. RESISTANCE TESTING FOUND THE LEAD WAS NOT ELECTRICALLY CONTINUOUS. DETAILED ANALYSIS CONFIRMED THAT THE INNER CONDUCTOR COIL HAD A BREAK AT THE DISTAL END OF 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

    HELIX TOOK 30-40 TURNS TO EXTEND FOR INITIAL PLACEMENT. LEAD THEN DISLODGED AND AFTER REPOSITIONED, THE HELIX EXTENSION COULD NOT BE CONFIRMED UNDER FLUORO AFTER 60-80 TURNS. EXERCISED OUTSIDE OF BODY AND HELIX WOULD NOT EXTEND. LEAD ATTEMPTED. NAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    50898 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7742 00802526523489

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 4076| 7741| 7742| L311