BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2173618 · Received July 23, 2011

    Report

    Report Number
    2124215-2011-12012
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 20, 2011
    Report Date
    July 19, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS LEAD IS NOT EXPECTED FOR RETURN. IF NEW INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE FURTHER EVALUATED AND UPDATED.

    Additional Manufacturer Narrative · 1

    MOST RECENTLY, THE BOSTON SCIENTIFIC LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE LEAD WOULD BE RETURNED TO BOSTON SCIENTIFIC.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS TRANSVENOUS RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED AS A RESULT OF EXHIBITING LOSS OF CAPTURE AND AND LOSS OF SENSING. THIS LEAD WAS REMOVED FROM SERVICE DURING THE NORMAL DEVICE CHANGEOUT. AT THIS TIME IT WAS NOT KNOWN IF THERE HAD BEEN ASYSTOLE GREATER THAN TWO BEATS.

    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 69 YR Required Intervention 4470| S601| 4457| 4471| 1298