BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 1945693 · Received January 4, 2011

    Report

    Report Number
    2124215-2010-20225
    Event Type
    Malfunction
    Date Received
    January 4, 2011
    Date of Event
    October 8, 2010
    Report Date
    November 16, 2010
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO AVAILABLE INFORMATION THIS LEAD WAS REMOVED AND RETURNED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS, THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT UPON RECEIPT TO THE (B)(4) LABORATORY, A VISUAL INSPECTION REVEALED CUTS IN THE SILICONE ABRASION SLEEVE 210 MM FROM THE TERMINAL PIN. THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION. THE HELIX IS RETRACTED. RESISTANCE AND PRESSURE TESTS WERE COMPLETED TO ASSESS THE LEADS ELECTRICAL PERFORMANCE AND INSULATION INTEGRITY. MEASUREMENTS THROUGHOUT THESE TESTS WERE WITHIN NORMAL LIMITS. THE HELIX FUNCTIONED APPROPRIATELY DURING ANALYSIS. ANALYSIS COULD NOT DETERMINE A REASON FOR THE REPORTED CLINICAL ALLEGATION.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT DURING THE IMPLANT PROCEDURE, DIFFICULTY WAS ENCOUNTERED POSITIONING THIS RIGHT VENTRICULAR LEAD DESPITE SEVERAL ATTEMPTS. A FURTHER ATTEMPT TO POSITION THIS LEAD IN THE RIGHT VENTRICLE SEPTAL POSITION REVEALED OVERSENSING ON THE RIGHT VENTRICULAR CHANNEL. IN ADDITION, THE HELIX WOULD NOT EXTEND OR RETRACT. IT WAS THOUGHT THIS LEAD HAD DISLODGED. THE LEAD WAS REMOVED, REPLACED WITH LEAD ((B)(4)). THE LEAD WILL BE RETURNED FOR ANALYSIS. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0295

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 5076| 0295| P108| 0285| 4591