BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINELINE II

    MDR report key: 3050093 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04873
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 14, 2013
    Report Date
    April 12, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE LEAD WAS THOROUGHLY INSPECTED AND ANALYZED. A TOTAL OF 536 MILLIMETERS (MM) OF THE LEAD HAD BEEN RETURNED. THE TIP OF THE LEAD WAS NOT RETURNED FOR ANALYSIS. STRETCHED CONDUCTOR COILS WERE NOTED TOWARD THE DISTAL END OF THE LEAD. THERE WAS A SLIGHT SEPARATION BETWEEN THE INSULATION AND THE PROXIMAL END OF THE ANODE ELECTRODE. MICROSCOPIC ANALYSIS SHOWED THAT THE ANODE AND CATHODE CONDUCTOR COILS WERE FLATTENED BETWEEN 290-305 MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE ALSO FRACTURED WITHIN THIS AREA AT APPROXIMATELY 292, 296, AND 302 MM FROM THE TERMINAL PIN. LEAD INSULATION DAMAGE WAS NOTED 303-317 MM FROM THE TERMINAL PIN. MICROSCOPIC ANALYSIS ALSO INDICATED THE INSULATION DAMAGE WAS INITIATED BY A LOCALIZED COMPRESSIVE STRESS ON THE TUBING SURFACE. IT WAS LIKELY THAT THE FRACTURED CONDUCTOR COILS WERE IN LINE WITH THE DAMAGED INSULATION, BUT DUE TO THE EXPLANT PROCEDURE, THE INSULATION AND CONDUCTOR COIL DAMAGE NO LONGER LINED UP. IT WAS DETERMINED THAT THE CAUSE OF DAMAGE THAT WAS SEEN WITH THE LEAD WAS LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/FIRST-RIB REGION.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD HAS NOT BEEN RETURNED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    THE LEAD HAS BEEN RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD DISPLAYED PACING IMPEDANCES OF GREATER THAN 2000 OHMS AND HIGH PACING THRESHOLDS THAT WERE IDENTIFIED DURING A ROUTINE FOLLOW UP APPOINTMENT. THE PATIENT UNDERWENT A LEAD REVISION PROCEDURE WHERE IT WAS IDENTIFIED THAT THE LEAD HAD FRACTURED AS A RESULT OF SUB-CLAVIAN CRUSH. THE LEAD WAS EXPLANTED AND REPLACED. THE LEAD IS TO BE RETURNED FOR ANALYSIS. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED. OF NOTE, THE PATIENT REPORTED THAT THEY HAD BEEN DOING SOME HEAVY LIFTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    154052 FINELINE II IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4480

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization| L| R K173| 4457| 4480