BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3040720 · Received April 8, 2013

    Report

    Report Number
    2124215-2013-00319
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    January 4, 2013
    Report Date
    April 3, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY A THOROUGH PRODUCT ANALYSIS WAS PERFORMED. VISUAL INSPECTION NOTED THE DISTAL END OF THE PROXIMAL SPRING ELECTRODE WAS SEPARATED FROM THE LEAD BODY INSULATION. THE PROXIMAL END OF THE DISTAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION. AS A RESULT, THE CLINICAL OBSERVATION WAS CONFIRMED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A FOLLOW-UP APPOINTMENT, AN X-RAY CONFIRMED THE RIGHT VENTRICULAR (RV) LEAD HAD CHANGED LOCATIONS. DURING THE REVISION PROCEDURE, THE LEAD WAS REMOVED AND THE DEFIBRILLATION COIL WAS LOOSE. AS A RESULT, THE LEAD WAS EXPLANTED AND REPLACED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143025 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R 0185| 0181| T177