BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 816347 · Received February 8, 2007

    Report

    Report Number
    2124215-2007-18756
    Event Type
    Injury
    Date Received
    February 8, 2007
    Date of Event
    October 5, 2006
    Report Date
    October 5, 2006
    Manufacturer
    CARDIAC PACEMAKERS, INC
    Product Code
    LWS
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    LAY USER/PATIENT

    Narratives

    Description of Event or Problem · 1

    EVENT DESCRIPTION BOSTON SCIENTIFIC, CRM RECEIVED INFORMATION THAT TWO LEFT VENTRICULAR (LV) LEADS (4542/113215 AND 4537/156100) WERE UNABLE TO BE SUCCESSFULLY IMPLANTED DUE TO PLACEMENT DIFFICULTY INTO SMALL BRANCHES. IT WAS LATER REPORTED THAT THIS RIGHT ATRIAL (RA) LEAD (4086/235091) DISLODGED. IT WAS REPOSITIONED AND AFTER THE SECOND DISLODGEMENT THE LEAD WAS REMOVED AND A NEW RA LEAD WAS IMPLANTED. DURING THAT PROCEDURE THE RIGHT VENTRICULAR DEFIBRILLATION LEAD (0184/127353) WAS ALSO EXPLANTED AS IT WAS AT RISK FOR COMPLETE DISLODGEMENT. A NEW RV LEAD WAS SUBSEQUENTLY IMPLANTED. THE PHYSICIAN SUSPECTED THAT THE ORIGINAL POCKET HAD BEEN MADE TO LOW, CAUSING THE DISLODGEMENT. DURING THAT PROCEDURE ANOTHER LV LEAD (4542/113285) WAS UNABLE TO BE SUCCESSFULLY IMPLANTED DUE TO THE PRESENCE OF DIAPHRAGMATIC STIMULATION AT INADEQUATE PACING THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS CARDIAC PACEMAKERS, INC 0184 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention