BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2170158 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-11426
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    October 11, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS THOROUGHLY INSPECTED AN ANALYZED. ONLY THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. THE OUTER INSULATION WAS SEVERED AT 21.2 CENTIMETERS FROM THE TERMINAL PIN. THE COILS WERE SITTING JUST INSIDE THE INSULATION AT APPROXIMATELY 21 CENTIMETERS FROM THE TERMINAL PIN. FURTHER ANALYSIS SHOWED EVIDENCE OF A CIRCULAR DEPRESSION AT THE LOCATION WHERE THE COILS ENDED WHICH COULD HAVE BEEN WHERE THE SUTURE SLEEVE TIE DOWN WAS. ANALYSIS DETERMINED THAT THE COILS' ENDS HAD BEEN CUT AND WERE NOT A FRACTURE SITE. THE RETURNED PORTION WAS DETERMINED TO BE ELECTRICALLY CONTINUOUS. THE CLINICAL OBSERVATIONS WERE NOT ABLE TO BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, NO ADDITIONAL INFORMATION IS AVAILABLE AND AT THIS TIME, OUR INVESTIGATION IS COMPLETE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE DEVICE CHECK, THIS RIGHT VENTRICULAR LEAD WAS NOTED TO NOT BE CAPTURING MYOCARDIAL TISSUE. PACING IMPEDANCES WERE ALSO NOTED TO HAVE BEEN GREATER THAN 2000 OHMS. THE PATIENT UNDERWENT A GENERATOR CHANGE OUT AND A LEAD REVISION. DURING THE LEAD REVISION, THE LEAD WAS NOTED TO HAVE FRACTURED. THE LEAD WAS CUT AND CAPPED AND REPLACED WITH ANOTHER BOSTON SCIENTIFIC LEAD. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Life Threatening| R 1194| 4457