BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3912366 · Received July 3, 2014

    Report

    Report Number
    2124215-2014-11391
    Event Type
    Injury
    Date Received
    July 3, 2014
    Date of Event
    April 28, 2014
    Report Date
    June 27, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY THE ALLEGATION AGAINS THE LEAD WAS NOT CONFIRMED. THE COMPLETE LEAD WAS RETURNED. PROXIMAL END OF THE DISTAL SPRING ELECTRODE IS SEPARATED FROM THE LEAD BODY INSULATION. HELIX WAS RETRACTED. BLOOD/BODY FLUID AND POSSIBLY TISSUE NOTED IN THE HELIX HOUSING. THE LEAD PASSED CONTINUITY TEST WITH MANIPULATION. THE LEAD ALSO PASSED HIPOT TEST AND HELIX MECHANISM. THE LEAD PASSED ELECTRICAL TESTING. THE LEAD TIP IS INTACT AND UNDAMAGED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS. THIS REPORT WILL BE UPDATED UPON RETURN AND COMPLETION OF ANALYSIS.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT RIGHT ATRIAL (RA) LEAD WAS DISLODGED AND HELIX WAS RETRACTED. IN ADDITION, THIS LEAD EXHIBITED HIGH PACING THRESHOLDS. THE LEAD WAS EXPLANTED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391922 ENDOTAK RELIANCE NVY CPI - DEL CARIBE 0292

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R 0292| 4542| 4087| N160| MISMATCH| E162