BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3210880 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-08785
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 2, 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

    AS OF TODAY, THIS RV LEAD 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 RIGHT VENTRICULAR (RV) LEAD EXHIBITED PACING IMPEDANCE MEASUREMENTS OF GREATER THAN 3,000 OHMS IN THE BIPOLAR PACING CONFIGURATION. THE MEASUREMENTS HAD BEEN OUT-OF-RANGE FOR THE PAST TEN MONTHS; IT WAS REPORTED THE LEAD HAD BEEN CHANGED TO THE UNIPOLAR CONFIGURATION. AT THE CURRENT DEVICE FOLLOW UP, OVERSENSING OF NOISE WAS OBSERVED ON THE ELECTROGRAMS, RESULTING IN PACING INHIBITION. SENSITIVITY IN THE RV WAS REPROGRAMMED TO AVOID OVERSENSING. A LEAD REVISION WAS PLANNED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED DUE TO THE RV LEAD ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310132 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4457

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R