BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THINLINE II

    MDR report key: 1953664 · Received January 10, 2011

    Report

    Report Number
    2124215-2010-23932
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 9, 2010
    Report Date
    December 9, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE DEVICE REPLACEMENT PROCEDURE, THE LEAD WAS EXPLANTED. THE LEAD IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS. 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 IMPLANTED WITH THIS LEAD WAS HOSPITALIZED FOR A DEVICE REPLACEMENT. OVERSENSING WAS NOTED, AND THE LEAD HAD A SINGLE DAILY PACING IMPEDANCE MEASUREMENT GREATER THAN 2,500 OHMS. A SUBCLAVIAN LEAD FRACTURE WAS SEEN ON X-RAY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 438-25S-52

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R