BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3213133 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-09788
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 2, 2013
    Report Date
    October 13, 2014
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT¿S RV LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE VIA THE PATIENT¿S MONITORING SYSTEM. THIS IS AN ON-GOING ISSUE; THE PATIENT IS CONTINUOUSLY MONITORED AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED ON THIS PATIENT A DAY PRIOR TO THE DETECTION OF ANOTHER OOR SLI MEASUREMENT. THE PHYSICIAN WILL FURTHER INVESTIGATE WITH THE CLINIC. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT A REVISION PROCEDURE WAS PERFORMED. THE DEVICE AND RV LEAD WERE EXPLANTED DUE TO INCREASED SHOCK IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NO ADVERSE PATIENT EFFECTS WERE REPORTED DURING THE PROCEDURE.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING EQUIPMENT DETECTED A HIGH OUT OF RANGE SHOCKING IMPEDANCE FOR THIS PATIENT'S RIGHT VENTRICULAR (RV) LEAD. THE PATIENT WAS BROUGHT IN FOR EVALUATION AND ISOMETETRICS WERE PERFORMED WHICH COULD NOT ILLICIT ANY ADDITIONAL OUT OF RANGE MEASUREMENTS. THE PHYSICIAN PLANS TO MONITOR THE LEAD FOR NOW. TO DATE, NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313833 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0185

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R N161| 4136| H210| 4538| 4470| 0185