BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 1951514 · Received January 6, 2011

    Report

    Report Number
    2124215-2010-23292
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    November 23, 2010
    Report Date
    December 13, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPRESENTATIVE LATER REPORTED THE X-RAY WAS NEGATIVE FOR A FRACTURE. THE PHYSICIAN ORDERED A RECHECK IN ONE MONTH. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    RESOLUTION WAS REQUESTED FROM THE FIELD. ALL AVAILABLE INFORMATION INDICATES THAT THE DEVICE REMAINS IN SERVICE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) DETECTED GREATER THAN 2000 OHMS ON THIS ATRIAL TRANSVENOUS LEAD. WITH HUGGING OR PULLING IMPEDANCES WERE 400 TO 800 OHMS AND NO NOISE WAS PRESENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE PHYSICIAN WAS TO FURTHER EVALUATE WITH AN X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR N119| 4592| 5076| 0185| 4470| 1297