BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210078 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-07149
    Event Type
    Injury
    Date Received
    July 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 20, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE LEAD WAS PERFORMED. THE COMPLETE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS AT 19.8 CM FROM IS-1 TERMINAL PIN. VISUAL INSPECTION REVEALED PROXIMAL SHOCKING COIL SLIGHTLY PARTED AND BOTH WIRES ARE FRACTURED APPROXIMATELY 34 CM FROM IS-1 PIN. THIS TYPE OF DAMAGE IS MOST LIKELY CAUSED BY ENTRAPMENT IN THE CLAVICLE/ FIRST-RIB REGION AND CONFIRMS THE CLINICAL ALLEGATION.

    Additional Manufacturer Narrative · 1

    AT THIS TIME THIS PRODUCT HAS NOT BEEN RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. THE LEAD WAS EXPLANTED. DURING THE PROCEDURE, A FRACTURE WAS NOTED DUE TO A SHARP BEND IN THE PROXIMAL COIL. THERE WERE NO ADDITIONAL ADVERSE PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309330 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R E110| 4469| 0184