BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS HE

    MDR report key: 1500631 · Received September 25, 2009

    Report

    Report Number
    1500631
    Event Type
    Injury
    Date Received
    September 25, 2009
    Date of Event
    September 11, 2009
    Report Date
    September 25, 2009
    Manufacturer
    BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION
    Product Code
    NIK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PRIMARY PROCEDURE OCCURRED FOR THE IMPLANT OF A COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND (RELIANCE ACTIVE FIX DUAL COIL) ENDOTAK RELIANCE G DEFIBRILLATION LEAD. THE ENDOTAK RELIANCE G/SG LEADS ARE STEROID-ELUTING, ENDOCARDIAL CARDIOVERSION/ DEFIBRILLATION, AND PACE/SENSE LEADS AVAILABLE IN EXTENDABLE ALSO INCLUDING A NEW LEFT VENTRICULAR AND A NEW RIGHT ATRIAL LEAD. WE RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS DEVICE THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS, WITH ALL OTHER MEASUREMENTS WITHIN ACCEPTABLE LIMITS. NO NOISE WAS OBSERVED ON THE RATE/SENSE CHANNEL OF THE LEAD. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND IT WAS FOUND THAT THE LEAD WAS FULLY INSERTED INTO THE DEVICE HEADER. WHEN THE IMPLANTING PHYSICIAN TUGGED ON THE LEAD, IT DID NOT PULL OUT OF THE HEADER. THE IMPEDANCE MEASURED 2300 OHMS WITH THE PACING SYSTEM ANALYZER (PSA). WHEN THE PHYSICIAN COULD NOT PULL THE LEAD OUT, HE IMPLANTED A NEW BRADY LEAD FOR THE PACE/SENSE PORTION OF THE DEVICE SYSTEM. BOTH THE LEAD AND DEVICE REMAIN IMPLANTED; HOWEVER, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT EXCEPT FOR RETURNING TO THE OR.

    Description of Event or Problem · 1

    THE PRIMARY PROCEDURE OCCURRED FOR THE IMPLANT OF A COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND (RELIANCE ACTIVE FIX DUAL COIL) ENDOTAK RELIANCE G DEFIBRILLATION LEAD. THE ENDOTAK RELIANCE G/SG LEADS ARE STEROID-ELUTING, ENDOCARDIAL CARDIOVERSION/ DEFIBRILLATION, AND PACE/SENSE LEADS AVAILABLE IN EXTENDABLE ALSO INCLUDING A NEW LEFT VENTRICULAR AND A NEW RIGHT ATRIAL LEAD. WE RECEIVED INFORMATION THAT ONE DAY POST IMPLANT OF THIS DEVICE THE RIGHT VENTRICULAR (RV) LEAD PACING IMPEDANCE MEASUREMENTS WERE GREATER THAN 2000 OHMS, WITH ALL OTHER MEASUREMENTS WITHIN ACCEPTABLE LIMITS. NO NOISE WAS OBSERVED ON THE RATE/SENSE CHANNEL OF THE LEAD. AN INVASIVE REVISION PROCEDURE WAS PERFORMED AND IT WAS FOUND THAT THE LEAD WAS FULLY INSERTED INTO THE DEVICE HEADER. WHEN THE IMPLANTING PHYSICIAN TUGGED ON THE LEAD, IT DID NOT PULL OUT OF THE HEADER. THE IMPEDANCE MEASURED 2300 OHMS WITH THE PACING SYSTEM ANALYZER (PSA). WHEN THE PHYSICIAN COULD NOT PULL THE LEAD OUT, HE IMPLANTED A NEW BRADY LEAD FOR THE PACE/SENSE PORTION OF THE DEVICE SYSTEM. BOTH THE LEAD AND DEVICE REMAIN IMPLANTED; HOWEVER, THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED. THERE WAS NO ADVERSE OUTCOME TO THE PATIENT EXCEPT FOR RETURNING TO THE OR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COGNIS HE DEFIBRILLATOR, CRT NIK BOSTON SCIENTIFIC CARDIOVASCULAR DIVISION N119 *
    2 ENDOTAK RELIANCE LEAD, DEFIBRILLATOR LWS BOSTON SCIENTIFIC 0157 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| O| R