BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3052575 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-03824
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    February 28, 2013
    Report Date
    May 21, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE AND LEADS REMAIN IMPLANTED. NO ADDITIONAL INFORMATION WAS ABLE TO BE OBTAINED OF THE POTENTIAL REVISION PROCEDURE PLANNED DUE TO THE PATIENT'S HEART BLOCK. AT A PREVIOUS FOLLOW UP, THE PHYSICIAN STATED THAT ALL MEASUREMENTS WERE STABLE AND WITHIN NORMAL RANGE. THE PATIENT HAD A PROVOCATION TEST IN THE ATRIUM AND VENTRICLE OF A COMPLETE EXIT BLOCK. DUE TO NO RETURN ON THIS DEVICE AND LEAD A ROOT CAUSE CAN NOT BE DETERMINED AT THIS TIME FOR THE LOSS OF CAPTURE (LOC). AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE AND LEADS REMAIN IMPLANTED. A FINAL REPORT WILL BE SENT AFTER INFORMATION IS RECEIVED OF THE REVISION PROCEDURE. IF THE PRODUCTS ARE RETURNED TO BOSTON SCIENTIFIC LABORATORY ANALYSIS WILL BE PERFORMED TO CONFIRM AND DETERMINE THE ROOT CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE, EXPERIENCED HEART BLOCK AND WAS SUBSEQUENTLY HOSPITALIZED. THE DEVICE WAS INTERROGATED AND A LOSS OF CAPTURE (LOC) GREATER THAN TWO SECONDS WAS OBSERVED ON THE RIGHT ATRIAL (RA) AND RIGHT VENTRICULAR (RV) LEAD. A REVISION PROCEDURE WAS SCHEDULED FOR THE NEAR FUTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154256 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R