BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 2053630 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-04279
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 2, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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 WITH THESE RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEADS REPORTED THAT THE LEADS WERE PULLED FROM THE ORIGINAL IMPLANTED SITE WHILE DOING HEAVY LIFTING. IT HAS ALSO BEEN ALLEGED THAT THIS ASSOCIATED DEVICE WAS ALSO DAMAGED AT THIS TIME. THE PATIENT NOTED THAT THEY FELT WEAK AND HAS CONTINUAL PAIN IN THE POCKET AREA. ATTEMPTS HAVE BEEN MADE TO FOLLOW UP WITH THE PATIENT TO HAVE THE DEVICE CHECKED. THE PATIENT HAS FAILED TO FOLLOW UP WITH THEIR PHYSICIAN. AT THIS TIME THE DEVICE AND LEADS REMAIN IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR 4469| S403| 4456