BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 1061403 · Received June 17, 2008

    Report

    Report Number
    2124215-2008-99910
    Event Type
    Injury
    Date Received
    June 17, 2008
    Date of Event
    May 20, 2008
    Report Date
    June 17, 2008
    Manufacturer
    GUIDANT PUERTO RICO B.V.
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NOT RETURNED. DURING IMMEDIATE SURGICAL INTERVENTION IN RESPONSE TO A CARDIAC TAMPONADE, A PERICARDIOCENTESIS WITH EVACUATION OF APPROX. 200CC OF BLOOD WAS PERFORMED. PACING THROUGH ELECTRODES WAS OBSERVED; HOWEVER, PHARMACOLOGICAL INOTROPIC SUPPORT AND EXTENSIVE MEDICAL INTERVENTION REMAINED UNSUCCESSFUL AT CONVERTING THE ELECTROMECHANICAL DISSOCIATION; THE PT EXPIRED. AN AUTOPSY WAS TO BE PERFORMED; HOWEVER, REPORTED INFO STATED NO PRODUCTS WERE TO BE RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CARDIAC RHYTHM MANAGEMENT (CRM) RECEIVED INFO THAT THIS PT UNDERWENT AN EXTRACTION OF A GUIDANT RV LEAD, DUE TO SEVERAL VENTRICULAR TACHYCARDIA RECORDED AT THE PM AND AT THE HOLTER; PHYSICIAN ELECTED TO EXTRACT AND REPLACE THE LEAD. THE PROCEDURE WAS NOTED UNREMARKABLE UNTIL THE IMPLANT OF THE NEW GUIDANT RIGHT VENTRICULAR DEFIBRILLATION LEAD, (MODEL 0185). POSITIONING DIFFICULTY OF THIS LEAD RESULTED IN UNSATISFACTORY PACING/SENSING MEASUREMENTS. AS A RESULT, THE LEAD WAS EXPLANTED AND ANOTHER GUIDANT RV LEAD (MODEL 0181) WAS SELECTED FOR IMPLANT. THIS LEAD WAS SUCCESSFULLY POSITIONED IN THE RV APEX; HOWEVER, PRIOR TO LEAD MEASUREMENTS, A SUDDEN BRADYCARDIA WITH HYPOTENSION WAS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE G IMPLANTABLE LEAD LWS GUIDANT PUERTO RICO B.V. 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention H145/104837| 4457/362134| 4480/438128| 4517/415247| 0181/106937