BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 1862144 · Received October 8, 2010

    Report

    Report Number
    2124215-2010-15804
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    July 28, 2010
    Report Date
    October 4, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    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 CRM RECEIVED INFORMATION THAT THIS PRODUCT WAS PART OF A SYSTEM EXPLANT DUE TO A PATIENT INFECTION. THERE WAS NO REPORT OF ADVERSE PATIENT EFFECTS DUE TO THE EXPLANT PROCEDURE.

    Description of Event or Problem · 1

    SUBSEQUENTLY, BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT HAS SOUGHT LEGAL REPRESENTATION AND INTENDS TO SEEK LEGAL ACTION AGAINST THE COMPANY. THE DOCUMENT CONTAINS INFORMATION CONCERNING A DEVICE MALFUNCTION ALLEGATION. ACCORDING TO THE DOCUMENT, THE PATIENT WAS REFERRED TO A PACEMAKER SPECIALIST DUE TO DEVICE MIGRATION, EROSION AND INFECTION. THE PATIENT HAD BEEN PRESENTED BACK TO THE ELECTROPHYSIOLOGY (EP) LABORATORY IN (B)(6) 2010 FOR EXTRACTION AND REPLACEMENT OF THE DEVICE/LEAD SYSTEM. ADDITIONALLY, THE ATTORNEY REPORTED THAT ALTHOUGH THIS DEVICE WAS NOT SUBJECT TO A RECALL, SEVERAL SERIAL NUMBERS FOR THIS MODEL PACEMAKER WERE SUBJECT TO A VOLUNTARY PHYSICIAN ADVISORY (HERMATIC SEALING COMPONENT) THAT WAS ISSUED IN (B)(6) 2005 AND AGAIN IN (B)(6) 2006. THE PATIENT'S ATTORNEY BELIEVES THAT THIS DEVICE DEFECT RESULTED IN THE NEED FOR DEVICE EXTRACTION AND REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| L| R 4469| 1280| 4456