BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FINELINE II

    MDR report key: 3061770 · Received April 16, 2013

    Report

    Report Number
    2124215-2013-06292
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 21, 2013
    Report Date
    March 22, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    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 THIS RIGHT ATRIAL (RA) LEAD HAS EXHIBITED OUT-OF-RANGE (OOR) IMPEDANCES OF GREATER THAN 2000 OHMS. A CHEST X-RAY WAS PERFORMED WHICH SHOWED A SEVERE BEND IN ONE OF THE LEADS, BUT IT IS UNCLEAR WHICH LEAD IT MAY BE. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONSULTED AND SUGGESTED IT COULD BE THE BEGINNING OF A LEAD FRACTURE. THE PHYSICIAN WILL MONITOR THE LEAD FOR NOW. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162379 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4470

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR 1853| 0184| T167| E110| 0157| 4470| 4086