BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3446310 · Received November 4, 2013

    Report

    Report Number
    2124215-2013-18742
    Event Type
    Injury
    Date Received
    November 4, 2013
    Date of Event
    July 26, 2013
    Report Date
    January 23, 2017
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL
    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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THIS SYSTEM WAS STILL EXHIBITING OUT OF RANGE SHOCKING IMPEDANCE MEASUREMENTS GREATER THAN 125 OHMS. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) WAS PERFORMED. THE PHYSICIAN INCREASED THE OUT OF RANGE LIMIT TO 175 OHMS AND WILL CONTINUE TO MONITOR THE PATIENT AND DATA FROM THE REMOTE MONITORING SYSTEM. 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 ANOTHER RED ALERT FOR HIGH, OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENT WAS DETECTED VIA THE PATIENT REMOTE MONITORING SYSTEM FOR THIS RIGHT VENTRICULAR (RV) LEAD. THE FIELD REPRESENTATIVE REPORTED THAT THIS PATIENT HAS NOT BEEN SEEN BY THE PHYSICIAN SINCE THE DEVICE CHANGEOUT. THE CAUSE OF THE OBSERVATION WAS NOT DETERMINED. THIS RV LEAD REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENTS OF 123-125 OHMS DURING DEVICE CHANGE OUT WHEN CONNECTED TO THE REPLACEMENT DEVICE. DEFIBRILLATION THRESHOLD (DFT) TESTING WAS PERFORMED AT IMPLANT BUT FAILED AT 14 J BUT WAS SUCCESSFUL AT 23 J WITH A RESULTING SHOCK LEAD IMPEDANCE MEASUREMENT OF 87 OHMS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN FELT THE HIGHER IMPEDANCE MEASUREMENTS WERE DUE TO REVISED TESTING SPECIFICATIONS. THE PHYSICIAN PLANS TO CONTINUE MONITORING THIS PATIENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565753 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0181

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| R E141| T175