BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2052897 · Received April 13, 2011

    Report

    Report Number
    2124215-2011-05763
    Event Type
    Injury
    Date Received
    April 13, 2011
    Date of Event
    February 17, 2011
    Report Date
    February 25, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT IN OUR POST MARKET QUALITY ASSURANCE LABORATORY, VISUAL OBSERVATIONS INDICATED A COMPLETE LEAD WAS RETURNED. THERE WERE SET SCREW MARKS NOTED ON ALL THE TERMINAL CONNECTORS, THE CLEAR MEDICAL ADHESIVE WAS SEPARATED/TORN FROM THE GORE AT THE PROXIMAL END OF THE SPRING ELECTRODE, AND THE PROXIMAL SPRING WAS STRETCHED AT THIS POINT. THIS LEAD PASSED ALL PATHS ON THE DIRECT CURRENT (DC) MEASUREMENT TEST. THIS RV LEAD DID NOT PASS THE HELIX MECHANISM TEST DUE TO DRIED BLOOD IN THE MECHANISM. RV LEAD FRACTURE WAS NOT CONFIRMED THROUGH ANALYSIS. DC RESISTANCE TEST SHOWED CONDUCTIVE PATHS TO BE IN SPECIFICATION.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED NOISY SIGNALS. THE PHYSICIAN TRIED RECREATING THE NOISE BY MOVING THE BOX AND LEAD INDIVIDUALLY, BUT WAS UNSUCCESSFUL. THE NOISE WAS RECREATED DURING PECTORAL FLEXING AND DEEP BREATHING. THE DECISION WAS MADE TO PERFORM A REVISION PROCEDURE. UPON DISCONNECTING THE RV PACE/SENSE PORTION OF THE LEAD, THE PHYSICIAN OBSERVED THAT THE PROXIMAL SET SCREW REQUIRED VERY LITTLE EFFORT TO RETRACT THE SCREW. THE LEADS WERE THEN TESTED THROUGH THE PACING SYSTEM ANALYZER (PSA), AND NO ABNORMAL IMPEDANCE MEASUREMENTS WERE OBSERVED. THE HEADER WAS THEN TESTED BY SLIGHTLY ROCKING THE HEADER SIDE TO SIDE, BUT NO IRREGULARITIES WERE OBSERVED. THE DECISION WAS MADE TO STILL EXPLANT THE RV LEAD BECAUSE THE PHYSICIAN FELT THE PATIENT WOULD BE MORE CONFIDENT WITH A NEW LEAD. RV LEAD FRACTURE WAS ALSO SUSPECTED. BOSTON SCIENTIFIC TECHNICAL SERVICES (BSC TS) REVIEWED ELECTROGRAMS (EGMS), AND IT WAS DISCUSSED THE NOISE CAUSED PACING INHIBITION OF GREATER THAN 2 SECONDS, AND WAS CONSISTENT WITH MYOPOTENTIALS. THE ORIGIN WAS MOST LIKELY ABDOMINAL/DIAPHRAGM ACTIVITIES. LEAD INSULATION DAMAGE IN THE POCKET AREA, OR A DAMAGED/MISSING SEAL PLUG COULD BE ANOTHER POSSIBLE REASON FOR THE NOISE. THERE WERE NO ADVERSE PATIENT EFFECTS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1