BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK ENDURANCE

    MDR report key: 2910655 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-15560
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    October 11, 2012
    Report Date
    November 29, 2012
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS OF THIS DATE, THIS RIGHT VENTRICULAR LEAD REMAINS IMPLANTED AND IN SERVICE. WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS EVENT WILL BE UPDATED.

    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

    ADDITIONAL INFORMATION WAS OBTAINED: A REVISION PROCEDURE WAS PERFORMED. VISUAL OBSERVATION CONFIRMED THE PINS WERE REVERSED IN THE HEADER. AFTER PLACING THEM IN THE CORRECT POSITION, DEFIBRILLATION THRESHOLD TESTING WAS NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, THE REPLACEMENT DEVICE WAS SUCCESSFULLY IMPLANTED AND CONNECTED TO THIS CHRONIC RIGHT VENTRICULAR LEAD. DEFIBRILLATION TESTING (DFT) WAS UNSUCCESSFUL AT 23 AND 41 JOULE SHOCKS. SOME UNDERSENSING WAS NOTED, HOWEVER, WAS SUFFICIENT TO INITIAL CORRECT DETECTION AND DEFIBRILLATION. AN ADDITIONAL 41 JOULE SHOCK WAS DELIVERED, WHICH SUCCESSFULLY TERMINATED THE VENTRICULAR FIBRILLATION. NORMAL SENSING WAS OBSERVED. THE PATIENT WAS DISCHARGED. DURING A FOLLOW-UP, THERE WAS CONCERN THAT THE DF-1 PINS MAY HAVE BEEN TRANSPOSED IN THE HEADER. AN INTERNAL TECHNICAL SERVICE CONSULTANT (TS) WAS CONTACTED FOR RECOMMENDATIONS. AFTER A REVIEW OF THE INFORMATION IT WAS STILL UNCLEAR WHETHER THE DF-1 PINS WERE TRANSPOSED. IT WAS RECOMMENDED FURTHER DFT TESTING BE PERFORMED IF THERE WAS STILL CONCERN. THE DEVICE SENSITIVITY WAS REPROGRAMMED. THE LEAD WAS LEFT PROGRAMMED TO TRIAD PACING AND THE DEVICE AND RIGHT VENTRICULAR LEAD REMAINED IN SERVICE. APPROXIMATELY, THREE WEEKS LATER, FURTHER FOLLOW UP WAS PERFORMED AND AN ELECTROGRAM WAS PROVIDED TO TS. AFTER REVIEWING THE DATA, TS DETERMINED THAT THE LEADS WERE LIKELY TRANSPOSED AND RECOMMENDED THAT EITHER FURTHER DFT TESTING BE PERFORMED OR A REVISION PROCEDURE TO VERIFY THE SYSTEM INTEGRITY. THIS INFORMATION WAS PROVIDED TO THE PHYSICIAN AND A REVISION IS INTENDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND THIS ISSUE DID NOT RESULT IN ANY LOSS OF THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18919 ENDOTAK ENDURANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0145

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| L| R 1783| E102| 0145| 1860