BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 2780528 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12867
    Event Type
    Injury
    Date Received
    October 10, 2012
    Date of Event
    August 15, 2012
    Report Date
    October 2, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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.

    Additional Manufacturer Narrative · 1

    THE LOCATION OF THESE LEADS IS UNKNOWN AT THIS TIME, THEREFORE THE CLINICAL OBSERVATION COULD NOT BE CONFIRMED AND DETERMINED FOR THESE LEADS; DUE TO NO RETURNED TO BOSTON SCIENTIFIC. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED AND AN AMENDED REPORT SUBMITTED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS RIGHT VENTRICULAR (RV) LEAD AND RIGHT ATRIAL (RA) LEAD (SERIAL NUMBER UNKNOWN AT THIS TIME) HAD BEEN REMOVED DUE TO AN INCREASE IN PACING IMPEDANCES GREATER THAN 3,000 OHMS. THE LOCATION OF THE LEADS IS UNKNOWN AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) AND RIGHT ATRIAL (RA) LEAD (SERIAL NUMBER UNKNOWN AT THIS TIME) WERE REMOVED DUE TO AN UNKNOWN LEAD FAILURE. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION HOWEVER NONE WAS ABLE TO BE OBTAINED. THE LOCATION OF THESE LEADS IS UNKNOWN AT THIS TIME NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 10074 DA Hospitalization| L| R 4470| 4471| 1763| 0181| 0125| 1831| MISMATCH| 497-24-60| 438-10| 1861| 497-24| (B)(4)| T167