BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2170263 · Received July 20, 2011

    Report

    Report Number
    2124215-2011-09512
    Event Type
    Injury
    Date Received
    July 20, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 29, 2011
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE (B)(4) LABORATORY, ONLY THE PROXIMAL PORTION OF THE LEAD WAS RETURNED. VISUAL INSPECTION CONFIRMED INSULATION DAMAGE AT 277-285 MM AND THE SUTURE SLEEVE HAD NOT BEEN SECURED. THE INSULATION DAMAGE MAY HAVE CONTRIBUTED TO THE LOWER THAN EXPECTED IMPEDANCE MEASUREMENTS AND MAY HAVE BEEN CAUSED BY ENTRAPMENT IN THE CLAVICLE-FIRST-RIB REGION. ANALYSIS DID NOT CONFIRM A LEAD FRACTURE. FURTHER DETAILED ANALYSIS REVEALED ARCING DAMAGE OF THE DISTAL AND PROXIMAL HIGH VOLTAGE CONDUCTOR CABLES. DUE TO THE ARCING DAMAGE, ANALYSIS COULD NOT CONFIRM WHETHER THERAPY COULD BE SUCCESSFULLY DELIVERED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW UP VISIT, IT WAS NOTED THIS RIGHT VENTRICULAR (RV) LEAD WAS FRACTURED. IMPEDANCE MEASUREMENTS WERE LOWER THAN EXPECTED. NO ISSUES WERE NOTED WITH THE LEFT VENTRICULAR LEAD. A REVISION PROCEDURE WAS PERFORMED. DURING THE LEAD REMOVAL, IT WAS NOTED THE LEFT VENTRICULAR LEAD (MODEL 4554 SN (B)(4)) WAS ADHERED TO THIS LEAD AND DISLODGED DURING THE RV LEAD REMOVAL. A DECISION WAS MADE TO REMOVE BOTH LEADS. UPON REMOVAL OF THIS LEAD, VISUAL INSPECTION REVEALED A FRACTURE AT THE SUTURE SLEEVE LOCATION. THIS LEAD WAS REPLACED SUCCESSFULLY AND 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 IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention