BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE SG

    MDR report key: 4140042 · Received October 3, 2014

    Report

    Report Number
    2124215-2014-16343
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    August 29, 2014
    Report Date
    October 8, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 THIS RIGHT VENTRICULAR (RV) LEAD HAD HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A REVIEW OF THE HISTORICAL IMPEDANCE MEASUREMENTS NOTED THAT THEY HAVE BEEN STEADILY INCREASING SINCE IMPLANT. THERE WAS NO EVIDENCE OF LOSS OF CAPTURE OR OVERSENSING. THE THRESHOLD MEASUREMENTS WERE ALSO NOTED TO HAVE INCREASED. THE PHYSICIAN FEELS THAT THE CLINICAL OBSERVATIONS ARE ATTRIBUTED TO THE PATIENT¿S RECENT WEIGHT GAIN AND NOT LEAD FRACTURE. THE PATIENT UNDERWENT TESTING WHICH RETURNED NORMAL SHOCK IMPEDANCE MEASUREMENTS. THE PATIENT WAS DISCHARGED HOME TO NORMAL FOLLOW UPS. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE AND LEAD REMAIN IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620722 ENDOTAK RELIANCE SG IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0181 323468

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| O| R 0181| F051| 0181| F051