BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 3212533 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09763
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    May 31, 2013
    Report Date
    October 8, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST-MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE LEAD WAS RETURNED IN TWO SEGMENTS, SEVERED 90 MILLIMETERS (MM) FROM THE TERMINAL PIN. VISUAL OBSERVATION NOTED THAT THE TERMINAL PIN WAS 0-90 MM, A PIECE OF THE ANODE COIL WAS RETURNED 90-160 MM AND WAS STRETCHED FROM 102-160 MM, THE TIP SEGMENT CATHODE COILS WERE 90-450 MM AND THE ANODE COILS WERE STRETCHED 119-122 MM. LEAD ON LEAD ABRASION WAS NOTED 145-150 MM FROM THE TERMINAL PIN AND SUTURE SLEEVE TIE DOWN MARKS WERE OBSERVED 235-240 MM FROM THE TERMINAL PIN. RESISTANCE TESTING WAS COMPLETED TO ASSESS LEAD ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. ANALYSIS DID NOT CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RECEIVED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. THE LEAD WAS OBSERVED TO HAVE FRACTURED. AN INVASIVE PROCEDURE WAS PERFORMED. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312395 TRANSVENOUS IMPLANTABLE LEAD NVN CPI - DEL CARIBE 4271

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| L| R K063| 1290| 4271| 1273| 4034| 4479