BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3912619 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-12913
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    June 8, 2014
    Report Date
    August 26, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    DTB
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE LEAD WAS SURGICALLY ABANDONED. AS THE LEAD WILL NOT BE RETURNED FOR ANALYSIS, THE CLINICAL OBSERVATIONS CANNOT BE CONFIRMED.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). 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 RECEIVED THAT THIS RIGHT ATRIAL (RA) LEAD WAS ABANDONED SURGICALLY.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD WAS BANGING ON THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE RA LEAD HAD DISLODGED. FURTHERMORE, THE FIELD REPRESENTATIVE DID NOT KNOW IF THE POSITION WAS CONFIRMED THROUGH X-RAY. THE RA WAS REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD MOVED AND WAS IN CONTACT WITH THE RIGHT VENTRICULAR (RV) LEAD. ADDITIONAL INFORMATION RECEIVED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE RA LEAD HAD DISLODGED. FURTHERMORE, THE FIELD REPRESENTATIVE DID NOT KNOW IF THE POSITION WAS CONFIRMED THROUGH X-RAY. THE RA WAS THEN REPOSITIONED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389629 FINELINE II IMPLANTABLE LEAD DTB CPI - DEL CARIBE 4469

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| L| R 4469| N161| 4549| 0180