BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 3905367 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-11020
    Event Type
    Injury
    Date Received
    July 1, 2014
    Date of Event
    May 9, 2014
    Report Date
    January 6, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073/S043
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A ROUTINE FOLLOW-UP APPOINTMENT, THE SHOCK IMPEDANCE MEASUREMENTS ON THE RIGHT VENTRICULAR (RV) LEAD WERE GREATER THAN 200 OHMS. AS A RESULT, THE PATIENT WAS HOSPITALIZED AND A DEFIBRILLATION THRESHOLD (DFT) TEST WAS PERFORMED TO VERIFY THE INTEGRITY OF THE SYSTEM. THE VENTRICULAR TACHYCARDIA (VT) WAS TERMINATED BY A 26 JOULE SHOCK AND THE SHOCK IMPEDANCE MEASUREMENT WAS 82 OHMS. ADDITIONALLY, A COMMITTED R-WAVE SYNCHRONOUS SHOCK WAS DELIVERED WITH 1.1 JOULE, IN WHICH THE SHOCK IMPEDANCE MEASUREMENT WAS 83 OHMS. AS A RESULT, NO CHANGES WERE MADE TO THE SYSTEM. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382264 ENDOTAK RELIANCE SG IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0181 305716

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention| L| H 0181| 4096| 4543| P107| 4096| 0181| P107| 4543