BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 13228488 · Received January 11, 2022

    Report

    Report Number
    2124215-2021-39364
    Event Type
    Injury
    Date Received
    January 11, 2022
    Date of Event
    November 9, 2021
    Report Date
    April 5, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NVY
    UDI-DI
    00802526431388
    PMA / PMN Number
    P910073/S077
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A GRADUAL INCREASE OF HIGH SHOCK IMPEDANCE MEASUREMENTS IN THE RIGHT VENTRICULAR (RV) LEAD OVER THE PAST YEAR. DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR THEIR REVIEW AND RECOMMENDATIONS. DATA WAS REVIEWED AND TROUBLESHOOTING WAS RECOMMENDED BY TS. PHYSICIAN DECIDED TO SCHEDULE A NEW FOLLOW UP. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXHIBITED A GRADUAL INCREASE OF HIGH SHOCK IMPEDANCE MEASUREMENTS IN THE RIGHT VENTRICULAR (RV) LEAD OVER THE PAST YEAR. DATA WAS SENT TO BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) FOR THEIR REVIEW AND RECOMMENDATIONS. DATA WAS REVIEWED AND TROUBLESHOOTING WAS RECOMMENDED BY TS. PHYSICIAN DECIDED TO SCHEDULE A NEW FOLLOW UP. AT THIS TIME, THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT PHYSICIAN PERFORMED INDUCTION TEST. IMPEDANCE MEASUREMENT WERE (B)(4). NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224377 ENDOTAK RELIANCE SG IMPLANTABLE LEAD NVY BOSTON SCIENTIFIC CORPORATION 0283 100771 00802526431388

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| H