BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2913746 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00400
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 20, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    PMA / PMN Number
    P960004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS RETAINED BY THE HOSPITAL AND IS NOT EXPECTED TO BE RETURNED. 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 VENTRICULAR (RV) LEAD EXHIBITED LOSS OF CAPTURE DURING ROUTINE FOLLOW-UP. THE PATIENT REPORTED THEY HAD EXPERIENCED A SYNCOPAL EPISODE A FEW MONTHS PRIOR AND HIT THEIR HEAD, HOWEVER DID NOT SEEK MEDICAL ATTENTION. THE CAUSE OF THE SYNCOPAL EPISODE WAS UNABLE TO BE DETERMINED. A MICRO-DISLODGEMENT OR EXIT BLOCK WERE SUSPECTED. AN INVASIVE PROCEDURE WAS PERFORMED. THIS LEAD WAS SUCCESSFULLY EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21094 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4471

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L| R S606| 4470| 4471