BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK DSP

    MDR report key: 1946570 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20648
    Event Type
    Injury
    Date Received
    January 4, 2011
    Date of Event
    October 20, 2010
    Report Date
    November 11, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Removal / Correction Number
    Z-1144/1145-9
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED LEAD HAD BEEN SEVERED 313 MM FROM THE TERMINAL PIN; ONLY THE PROXIMAL SECTION OF THE PRODUCT RETURNED. SETSCREW MARKS WERE NOTED ON ALL TERMINALS; BLOOD/BODY FLUID OBSERVED WITHIN THE LEAD LUMENS. TRILUMEN INSULATION ABRASION NOTED THROUGH TO THE RATE/SENSE LUMEN 230-242 MM FROM THE IS-1 TERMINAL PIN. THE WEAR PATTERN APPEARED TO SPIRAL AROUND THE LEAD SLIGHTLY, WITH ONLY ONE COMPROMISED INSULATION INTEGRITY NOTATION. MICROSCOPIC ANALYSIS SHOWED THAT THE OUTER CONDUCTOR COIL HAD BEEN DEFORMED/BENT AND TIGHT ON THE INNER INSULATION. THE OUTER COILS HAD BEEN TRAPPED UNDER THE EDGE OF THE IS-1 RING. TECHNICIANS THEN LIGHTLY STRETCHED THE LEAD, CONFIRMING THE COIL HAD TORN THROUGH THE INNER INSULATION AT THIS POINT. LABORATORY ANALYSIS CONFIRMED PRODUCT DAMAGE HOWEVER, IT IS UNKNOWN IF THE OBSERVED DAMAGE WAS DUE TO OR EFFECTED BY, THE EXPLANT AND/OR LEAD PLACEMENT PROCEDURES.

    Additional Manufacturer Narrative · 1

    FOLLOWING PRODUCT RETURN, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS LEAD EXHIBITED HIGH THRESHOLDS VALUES AND FLUCTUATING PACING IMPEDANCES FROM 600 UP TO 2000 OHMS; AS A RESULT, THE PRODUCT WAS EXPLANTED. THE LEAD WAS ONLY PARTIALLY EXTRACTED WITH AN IN SERVICE LIFE OF 14 YEARS. THE EXPLANTED SECTION IS TO BE RETURNED FOR POST MARKET EVALUATION. NO ADVERSE PATIENT EFFECTS REPORTED AND REPLACEMENT NOTED SUCCESSFUL WITH ANOTHER BOSTON SCIENTIFIC PRODUCT.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK DSP IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0125

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention