BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3043260 · Received April 9, 2013

    Report

    Report Number
    2124215-2013-02132
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    January 24, 2013
    Report Date
    February 4, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE PATIENT WAS BROUGHT IN FOR A LEAD REVISION. THIS LEAD WAS SURGICALLY ABANDONED AND A NEW LEAD OF THE SAME MODEL WAS SUCCESSFULLY IMPLANTED. THE LEAD WAS TESTED FOUR DAYS POST-LEAD REPLACEMENT, WITH NORMAL LEAD MEASUREMENTS OBSERVED. DEVICE INTERROGATION CONFIRMED NO NOISE WAS PRESENT, AND NO EPISODES WERE STORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. AS THE LEAD WILL NOT BE RETURNED, CLINICAL OBSERVATIONS CANNOT BE CONFIRMED. AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    AS OF TODAY, THE LEAD REMAINS IMPLANTED WITH NO INTERVENTION PERFORMED. THIS INVESTIGATION WILL BE UPDATED WHEN ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT IMPLANTED WITH THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD EXPERIENCED A SYNCOPAL EVENT. A SHORT EPISODE OF NOISE ON THE RV CHANNEL WAS DETECTED AS VENTRICULAR TACHYCARDIA (VT) BUT NO THERAPY WAS DELIVERED. AN X-RAY WAS PERFORMED AND IT WAS NOTED THAT ONE LEAD APPEARED TO BE FRACTURED; HOWEVER, IT WAS NOT DETERMINED WHICH LEAD HAD THE FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE NEXT STEPS FOR THIS PATIENT AND LEAD HAVE NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145278 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| L| R 4076| 4087| 0185| 4549| N107