BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3053098 · Received April 11, 2013

    Report

    Report Number
    2124215-2013-04603
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 5, 2013
    Report Date
    March 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 WAS HOSPITALIZED FOR CHEST PAIN AND UPON INTERROGATION, IT WAS NOTED THAT THE LEAD SAFETY SWITCH HAD TRIPPED FOR THE RIGHT VENTRICULAR (RV) LEAD DUE TO HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS. FURTHER EVALUATION FOUND COMPLETE LOSS OF CAPTURE AT MAXIMUM OUTPUTS AND NO SENSING. IT WAS NOTED THAT THE PATIENT'S PRESENTING RHYTHM WAS ATRIAL FIBRILLATION WITH A VENTRICULAR RESPONSE IN THE MID 40 BPM RANGE. REVIEW OF THE DAILY MEASUREMENTS SHOWED A SIGNIFICANT INCREASE IN THE IMPEDANCE MEASUREMENT APPROXIMATELY NINE DAYS EARLIER. THE PATIENT STATED THAT SHE DID NOT FEEL LIGHTHEADED OR DIZZY AND THERE HAD BEEN NO CHANGE IN HER DAILY ROUTINE. SUBSEQUENTLY A REVISION PROCEDURE WAS PERFORMED WHERE THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD WAS SUCCESSFULLY IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    155942 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4473

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| L| R 4473| 1290| S601| 4472