BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2911806 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16542
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 1, 2012
    Report Date
    March 14, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    NVY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE COMPLETE LEAD WAS RETURNED SEVERED IN TWO SEGMENTS AT 15.5 CM FROM THE IS-1 PIN. THE RATE SENSE (-) MEASUREMENT WAS UNABLE TO BE PERFORMED DUE TO THE EXTRACTING STYLET REMAINING INTACT, HOWEVER, ALL OTHER DIRECT CURRENT TESTING WAS WITHIN ACCEPTABLE LIMITS. AN X-RAY EXAMINATION REVEALED ALL CONDUCTORS ARE INTACT, WITH NO FRACTURE OBSERVED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD DISPLAYED INCREASING SHOCK IMPEDANCE MEASUREMENTS IN THE 50 OHMS RANGE TO 100 OHMS, ULTIMATELY REACHING GREATER THAN 125 OHMS. PACING IMPEDANCE MEASUREMENTS HAVE INCREASED FROM 400 OHMS TO 680 OHMS. ALL OTHER LEAD MEASUREMENTS WERE WITHIN ACCEPTABLE LIMITS AND STABLE. A LEAD REVISION PROCEDURE WAS PERFORMED AND THE RV LEAD WAS SURGICALLY EXPLANTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE. LEAD RETURN WAS REQUESTED TO ALLOW FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17796 ENDOTAK RELIANCE IMPLANTABLE LEAD NVY CPI - DEL CARIBE 0180

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| L| R N141| T175| 4542| MISMATCH| 0180