BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050076 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-03706
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS SUCCESSFULLY EXPLANTED AND REPLACED. LEAD MEASUREMENTS WERE OBSERVED TO BE WITHIN NORMAL LIMITS WHEN CONNECTED TO A PACING SYSTEM ANALYZER (PSA). THE LEADS REMAIN IMPLANTED AND IN SERVICE WITH THE REPLACEMENT DEVICE. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD), RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD UNDERWENT A CARDIOVERSION FOR ATRIAL FIBRILLATION (AF). TWO COMMANDED SHOCKS WERE DELIVERED THROUGH THE DEVICE IN ADDITION TO EXTERNAL SHOCKS. SUBSEQUENTLY, THE PATIENT PRESENTED TO THE HOSPITAL WITH COMPLAINT OF CHEST PAIN. INTERROGATION OF THE DEVICE REVEALED THAT THE RA AND RV LEADS EXHIBITED LOW OUT OF RANGE PACING IMPEDANCE MEASUREMENTS EVER SINCE THE CARDIOVERSION. ADDITIONALLY, THE RV LEAD EXHIBITED LOW OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED THE POSSIBILITY THAT THE DEVICE WAS DAMAGED BY THE CARDIOVERSION AND RECOMMENDED REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152180 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R 0184| E030| 4473