BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGEVITY

    MDR report key: 6195487 · Received December 21, 2016

    Report

    Report Number
    2124215-2016-20757
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Date of Event
    November 28, 2016
    Report Date
    December 14, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION NOTED THE LEAD WAS RETURNED WITH THE STYLET INSIDE, THE HELIX WAS RETRACTED AND DRIED BLOOD/TISSUE WAS PRESENT AROUND THE HELIX. ADDITIONALLY, THE CRIMP SLEEVE WAS NOTED TO BE MIGRATED SLIGHTLY DISTAL. 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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE ATTEMPTED IMPLANT OF THIS LEAD IN THE RIGHT ATRIUM, THE HELIX WOULD NOT EXTEND. THE HELIX WAS REMOVED AND EXERCISED OUTSIDE OF THE BODY AND THE HELIX STILL WOULD NOT EXTEND. A FRACTURE WAS SUSPECTED TOWARDS THE BOTTOM OF THE LEAD BODY, HOWEVER, WAS NOT CONFIRMED THROUGH DIAGNOSTIC IMAGING. THE LEAD WAS ATTEMPTED, BUT NOT IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    846122 INGEVITY IMPLANTABLE LEAD NVN CPI - DEL CARIBE 7741

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR 5076| 7741| 7742| L321