BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THINLINE II

    MDR report key: 2052794 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04074
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 28, 2011
    Report Date
    February 28, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RELATED DEVICE WAS REPROGRAMMED TO UNIPOLAR MODE, AND THE PHYSICIAN ELECTED NOT TO PERFORM A REVISION PROCEDURE. 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 THIS RIGHT VENTRICULAR (RV) LEAD HAD EXHIBITED LOSS OF CAPTURE, RESULTING IN ASYSTOLE FOR A PERIOD OF THREE SECONDS. THE PATIENT FELT SICK AT THE TIME OF ASYSTOLE. A LEAD FRACTURE WAS SUSPECTED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THINLINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 430-35S-58

    Patients

    Seq Age Sex Outcome Treatment
    1