BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2911962 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16605
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 4, 2012
    Report Date
    December 13, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX
    Reporter Occupation
    PHYSICIAN

    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

    ADDITIONAL INFORMATION INDICATED THAT THE RV LEAD HAD STRAIGHTENED OUT UNDER X-RAY AND WAS SHOWING INCREASED THRESHOLD MEASUREMENTS AND LOSS OF SENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD DEVELOPED TWIDDLER'S SYNDROME AND EXPERIENCED DIAPHRAGMATIC STIMULATION. A REVISION PROCEDURE WAS PERFORMED AND THE LEAD WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    16701 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4456

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| L| R K063| 4456| 4469