BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3911682 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-11276
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    May 6, 2014
    Report Date
    February 6, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    Reporter Occupation
    PATIENT

    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 HAD AN X-RAY EXAMINATION AND THE PRINT OUT READ THAT THE LEADS NEAR BATTERY PACK SEEMS TO BE FRACTURED. HOWEVER, THE PATIENT DID NOT KNOW WHICH LEAD THE REPORT REFERRED TO. BOSTON SCIENTIFIC COMPANY REPRESENTATIVE REFERRED PATIENT TO THE PHYSICIAN. ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER WERE UNSUCCESSFUL. ALL AVAILABLE INFORMATION INDICATES THAT THIS RIGHT VENTRICULAR (RV) LEAD REMAINS IMPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED. THERE WAS NO FURTHER INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390989 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Hospitalization| L| R 4086| S603| 4456