BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 16597827 · Received March 23, 2023

    Report

    Report Number
    2124215-2023-13707
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    July 14, 2011
    Report Date
    October 25, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526531255
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH OUT OF RANGE SHOCK IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) IS TO BE SCHEDULED FOR FURTHER TROUBLESHOOTING. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION BECOMES AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION WAS RECEIVED. NIPS TESTING WAS PERFORMED. PRIOR TO TESTING, HIGH SHOCK IMPEDANCES RANGING FROM 140-144 OHMS WERE NOTED. IMPEDANCES THROUGHOUT THE TESTING RANGED FROM 85-93 OHMS, WITH NO ANOMALIES NOTED. HOWEVER, WITHIN 5 DAYS OF THE TESTS, THE IMPEDANCES INCREASED TO A RANGE OF 128-145 OHMS. NO NOISE OR ARTIFACT WAS OBSERVED. TECHNICAL SERVICES REVIEWED THE CASE, AND SUGGESTED TO REPEAT THE NIPS PROCEDURE, OR LEAD REPLACEMENT. THIS DEVICE SYSTEM REMAINS IN-SERVICE AT THIS TIME. ASIDE FROM THE PERFORMED NIPS PROCEDURE, NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH OUT OF RANGE SHOCK IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) IS TO BE SCHEDULED FOR FURTHER TROUBLESHOOTING. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION BECOMES AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT HIGH OUT OF RANGE SHOCK IMPEDANCES WERE NOTED ON THIS RIGHT VENTRICULAR (RV) LEAD. NON-INVASIVE PROGRAMMED STIMULATION (NIPS) IS TO BE SCHEDULED FOR FURTHER TROUBLESHOOTING. THIS INVESTIGATION WILL BE UPDATED WHEN FURTHER INFORMATION BECOMES AVAILABLE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427433 ENDOTAK RELIANCE SG IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0293 015326 00802526531255

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Unknown Hospitalization| R