BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 4150923 · Received October 8, 2014

    Report

    Report Number
    2124215-2014-17042
    Event Type
    Injury
    Date Received
    October 8, 2014
    Date of Event
    August 28, 2014
    Report Date
    May 29, 2015
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ALL AVAILABLE INFORMATION INDICATES THAT THE LEAD REMAINS IN SERVICE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A SUBSEQUENT SHOCK IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS WAS OBSERVED. ELECTROMAGNETIC INTERFERENCE (EMI) WAS SUSPECTED, HOWEVER, UNCONFIRMED. THE PATIENT'S HEALTHCARE TEAM WAS TO CONTINUE MONITORING THE DEVICE SYSTEM.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS CONTINUED, SUBSEQUENTLY THE RIGHT VENTRICULAR (RV) LEAD WAS SURGICALLY ABANDONED . THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH SHOCKING LEAD IMPEDANCE MEASUREMENT GREATER THAN 125 OHMS. IMPEDANCE TESTING IN ALL VECTORS INDICATED NO NOISE ON SHOCK CHANNEL. COMMANDED SHOCKS WERE PERFORMED AND RESULTS WERE WITHIN NORMAL RANGE. THE PHYSICIAN WILL CONTINUE TO MONITOR THIS PATIENT. ADDITIONAL INFORMATION OBTAINED FROM THE FIELD REPRESENTATIVE INDICATED THAT THE CAUSE WAS NOT DETERMINED. THIS DEVICE AND LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633625 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| L| R E143| 0184| T167| 4470