BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSVENOUS

    MDR report key: 2050460 · Received April 12, 2011

    Report

    Report Number
    2124215-2011-03364
    Event Type
    Injury
    Date Received
    April 12, 2011
    Date of Event
    February 17, 2011
    Report Date
    January 7, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED AT THIS TIME, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    APPROXIMATELY THREE MONTHS LATER THE LEAD WAS RETURNED TO BOSTON SCIENTIFIC. THERE WAS NO PAPERWORK RETURNED WITH THE LEAD SO IT IS UNKNOWN WHEN AND WHY THE LEAD WAS EXPLANTED. THE LEAD IS CURRENTLY IN ANALYSIS. UPON COMPLETION FROM ANALYSIS, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE LEAD WAS RETURNED SEVERED AT 71 MM FROM THE TERMINAL PIN. TWO SEGMENTS WERE RETURNED. THE LEAD TIP SEGMENT, INNER CONDUCTOR AND INNER INSULATION OF THE MID-BODY SEGMENT WERE NOT RETURNED. SETSCREW MARKS WERE NOTED ON THE TERMINAL PIN AND RING ASSEMBLY. CONDUCTOR COILS WERE DEFORMED IN A FEW LOCATIONS ON THE LEAD. PUNCTURE HOLES WERE ALSO OBSERVED IN THE INSULATION. BLOOD AND BODY FLUID WAS PRESENT IN THE LEAD'S LUMEN. OF THE SEGMENTS RETURNED, RESISTANCE TESTING WAS COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE. MEASUREMENTS THROUGHOUT THIS TEST WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO REPRODUCE THE REPORTED CLINICAL OBSERVATIONS, HOWEVER THE LEAD SEGMENTS RETURNED PASSED ELECTRICAL TESTING.

    Description of Event or Problem · 1

    EIGHT MONTHS LATER, THE PATIENT WAS SEEN FOR A DEVICE FOLLOW UP APPOINTMENT. THE DEVICE CHECK REVEALED 5,400 ATRIAL TACHY RESPONSE EPISODES WHICH ARE NOISE AND VERY BRIEF IN DURATION. ATRIAL IMPEDANCES HAVE BEEN FLUCTUATING AND SOME MEASUREMENTS RANGE LESS THAN 100 OHMS. IMPEDANCES TESTED IN UNIPOLAR WERE LOWER IN VALUE AS WELL. IT WAS NOTED THAT THE PACEMAKER WAS REPLACED A COUPLE MONTHS AGO AND THE ATRIAL MEASUREMENTS NORMAL. THE PATIENT IS SCHEDULED TO BE SEEN AGAIN BY THEIR PHYSICIAN ONCE HE RETURNS FROM VACATION.

    Description of Event or Problem · 1

    APPROXIMATELY THREE YEARS LATER, THE ATRIAL LEAD WAS SURGICALLY ABANDONED DUE TO ONGOING ISSUES WITH LOW IMPEDANCE MEASUREMENTS AND OVERSENSING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE LEAD SAFETY SWITCH TRIGGERED ON THIS RIGHT ATRIAL LEAD TO UNIPOLAR CONFIGURATION. P-WAVE MEASUREMENTS WERE LOW AT 0.9MV IN UNIPOLAR CONFIGURATION AND THE LEAD IMPEDANCE MEASUREMENTS WERE AT 400 OHMS IN BIPOLAR. NO TROUBLESHOOTING WAS DONE TO ATTEMPT TO RECREATE THE LEAD IMPEDANCE CHANGE, HOWEVER THE PATIENT WILL BE SEEN AGAIN FOR A DEVICE CHECK IN 3 MONTHS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| L| R 1270| 4271| 4171| 1290| 4035