BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II STEROX

    MDR report key: 2040726 · Received April 6, 2011

    Report

    Report Number
    2124215-2011-00722
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 7, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO RETURN OF PRODUCT IS INTENDED, BOSTON SCIENTIFIC CANNOT CONFIRM NOR DENY THIS REPORTED CLINICAL ALLEGATION. 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 RECEIVED INFORMATION THAT THE PATIENT WITH THIS ATRIAL LEAD DID NOT FEEL WELL AND PRESENTED TO THE HOSPITAL. AN ELECTROGRAM REVEALED NO ATRIAL PULSE. AN X-RAY WAS PERFORMED REVEALING THIS LEAD WAS FRACTURED AT THE SUTURE SLEEVE SITE, HOWEVER, NOT AT THE SUTURE AREA. THE LEAD WAS SURGICALLY ABANDONED AND REPLACED. DURING THE SAME PROCEDURE, THE DEVICE WAS ALSO REPLACED. THE PATIENT HAD REPORTED EXPERIENCING HEART FAILURE SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II STEROX IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4376

    Patients

    Seq Age Sex Outcome Treatment
    1 Other