BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3041194 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-02205
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    April 24, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    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. TWO SEGMENTS OF THE LEAD WERE RETURNED; IT WAS SEVERED AT 150 MM FROM THE TERMINAL PIN AND THE MID-BODY SEGMENT OF THE LEAD APPEARED TO BE MISSING. SET SCREW MARKS WERE NOTED ON THE TERMINAL PIN. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION AND MEDICAL ADHESIVE WAS NOTED. THE HELIX WAS VERY STRETCHED. RESISTANCE TESTS WERE COMPLETED TO ASSESS THE ELECTRICAL PERFORMANCE OF THE LEAD. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. LABORATORY TESTING WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED DUE TO THE OVERSENSING. THIS RV LEAD WAS EXPLANTED AND A COMPETITOR'S RV LEAD WAS IMPLANTED; THE GENERATOR REMAINS IN SERVICE. IT WAS NOTED THAT THE LEAD WOULD NOT BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM EXPERIENCED A SYNCOPAL EPISODE, BUT WAS NOT HURT. UPON EVALUATION, NOISE WITH OVERSENSING WAS NOTED AND THIS RESULTED IN AT LEAST FOUR SECONDS OF PACING INHIBITION IN THIS DEPENDENT PATIENT. NO NOISE WAS ABLE TO BE REPRODUCED IN CLINIC, AND THE PHYSICIAN REPROGRAMMED THE RV SENSITIVITY. IT WAS NOTED THAT THE PATIENT WAS IN AN AREA OF A LOT OF POWER LINES AT THE TIME OF THE EVENT. A SUBSEQUENT EVALUATION WAS PERFORMED AND A STORED EPISODE FOR TRUE NONSUSTAINED VENTRICULAR TACHYCARDIA, SHOWED NOISE ON THE LEAD WHILE THE PATIENT WAS EXERCISING, BUT PACING INHIBITION WAS LESS THAN TWO SECONDS LONG. TROUBLESHOOTING AND EVALUATION OPTIONS WERE DISCUSSED WITH THE FIELD REPRESENTATIVE. NO ADDITIONAL ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. AT THIS TIME, THE PHYSICIAN HAS DECIDED TO MONITOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143690 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R 4542| N140| 0295| 4086| 1297| 4087