BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK C

    MDR report key: 3041204 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-05520
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 16, 2013
    Report Date
    January 16, 2013
    Manufacturer
    HISTORICAL CPI ST. PAUL
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD SYSTEM RECEIVED SEVEN SHOCKS FOR SUPRAVENTRICULAR TACHYCARDIA (SVT). IT WAS NOTED THAT THE PATIENT'S LOWEST ZONE HAD A RATE CUT-OFF OF 115 BPM. THE FIELD REPRESENTATIVE REPORTED THAT A TECHNICIAN HAD INTERROGATED THE DEVICE AND HAD SEEN A "SHORTED LEAD CONDITION" MESSAGE WHICH WAS THEN CLEARED. WHEN THE FIELD REPRESENTATIVE INTERROGATED THE DEVICE THE MESSAGE WAS NO LONGER PRESENT. SHOCK LEAD IMPEDANCE MEASUREMENTS WERE NORMAL WHEN TESTED AND NO NOISE WAS NOTED ON THE LEAD. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) DISCUSSED WITH THE FIELD REPRESENTATIVE THAT LIKELY THE SHORTED LEAD CONDITION WAS OFF A DELIVERED SHOCK; THE IMPEDANCES FROM THE SHOCKS WERE NOT AVAILABLE. IT WAS REVIEWED THAT CHRONIC DAMAGE TO THE CIRCUIT MAY HAVE OCCURRED AND THAT THE LEAD AND DEVICE SHOULD BE CONSIDERED DAMAGED AND NEED TO BE REPLACED AS THERAPY MAY NOT BE AVAILABLE. THE FIELD REPRESENTATIVE AS GOING TO REVIEW THE INFORMATION WITH THE PHYSICIAN. ADDITIONAL INFORMATION WAS RECEIVED THAT SURGICAL INTERVENTION WAS PERFORMED AND THE ICD WAS EXPLANTED AND THE RV LEAD WAS SURGICALLY ABANDONED. IT WAS REPLACED WITH A COMPETITOR'S DEVICE, AND SO IT IS UNKNOWN IF THE ICD WILL BE RETURNED FOR ANALYSIS. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142551 ENDOTAK C IMPLANTABLE LEAD NVY HISTORICAL CPI ST. PAUL 0064

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| L| R 0064| 1746| 1725| 1858| 1600| 1388T