BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173306 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-10562
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 15, 2011
    Report Date
    August 3, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RV LEAD WILL BE RETURNED TO BOSTON SCIENTIFIC FOR LABORATORY ANALYSIS. AT THIS TIME THERE IS NO ADDITIONAL INFORMATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL INSPECTION REVEALED LEAD COILS AND INSULATION IS DAMAGED (FRACTURE). THIS TYPE OF DAMAGE IS CONSISTENT WITH REPEATED STRESS OVER TIME. IN THIS CASE, WE BELIEVE THE STRESS WAS THE RESULT OF CLAVICULAR/FIRST-RIB ENTRAPMENT. THE REPORTED DELIVERY OF INAPPROPRIATE THERAPY IS LIKELY THE RESULT OF THE LEAD DAMAGE OBSERVED BY THE LABORATORY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD, WHICH WAS IMPLANTED FOR PACE/SENSE PURPOSES, WAS EXPLANTED AND REPLACED DUE TO A FRACTURE AND THE DELIVERY OF INAPPROPRIATE SHOCKS. THE ASSOCIATED RV LEAD, WHICH WAS IMPLANTED FOR SHOCKING PURPOSES, WAS ALSO EXPLANTED. IT WAS ALSO NOTED THE SHOCKING MEASUREMENTS WERE WITHIN RANGE, BUT THE PHYSICIAN VIEWED THEM AS BEING INADEQUATE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4474

    Patients

    Seq Age Sex Outcome Treatment
    1 0181| 0128| T175| 4474| 1860