BEUDAMED
    FDA Adverse Event Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 1681574 · Received May 7, 2010

    Report

    Report Number
    2124215-2010-09889
    Date Received
    May 7, 2010
    Report Date
    July 20, 2010
    Product Code
    OJX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLETE LEAD WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION NOTED DRIED BLOOD/BODY FLUID IN THE ENTIRE LEAD LUMEN. THE CONDUCTOR COILS WERE FRACTURED AT 505 MILLIMETERS(MM) FROM THE TERMINAL PIN. THE POLYURETHANE WAS BENT AT 505 AND 510 MM FROM THE TERMINAL PIN. THE POLYURETHANE WAS PUCKERED 482 - 488 MM FROM THE TERMINAL PIN. THE INNER INSULATION WAS WORN AT 505 MM FROM THE TERMINAL PIN. THE CONDUCTOR COILS WERE ALSO DEFORMED 143 MM AND 257 MM FROM THE TERMINAL PIN. CUTS WERE NOTED IN THE POLYURETHANE INSULATION AT 295 AND 501 MM FROM THE TERMINAL PIN. FLATTENED/CRUSHED COILS WERE NOTED AT 118 - 122, 131 - 133 AND 289 - 294 MM FROM THE TERMINAL PIN WHICH WERE MOST LIKELY A RESULT OF A GRABBING TOOL. ANALYSIS WAS ABLE TO CONFIRM THE CLINICAL OBSERVATION OF A LEAD FRACTURE THROUGH VISUAL INSPECTION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING A LEFT VENTRICULAR (LV) THRESHOLD TEST THIS LEAD EXHIBITED LOSS OF CAPTURE (LOC). PACING IMPEDANCES OF GREATER THAN 2000 OHMS WERE ALSO RECORDED. DURING THE THRESHOLD TEST, THE PATIENT HAD A VERY BRIEF SYNCOPAL EPISODE DUE TO THE LOC. A CHEST X-RAY WAS PERFORMED AND A LEAD FRACTURE WAS CONFIRMED. THE PATIENT IS CURRENTLY SCHEDULED FOR AN LV LEAD REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SUBSEQUENT INFORMATION INDICATES THAT THE LEAD HAS BEEN EXPLANTED AND HAS BEEN RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IMPLANTABLE LEAD OJX

    Patients

    Seq Age Sex Outcome Treatment
    1