BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDOTAK RELIANCE G

    MDR report key: 3921730 · Received July 9, 2014

    Report

    Report Number
    2124215-2014-12383
    Event Type
    Injury
    Date Received
    July 9, 2014
    Date of Event
    April 29, 2014
    Report Date
    February 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    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.

    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.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WITH THE RIGHT VENTRICULAR (RV) LEAD EXHIBITED HIGH OUT-OF-RANGE (OOR) SHOCK LEAD IMPEDANCE MEASUREMENTS. HIGH OOR MEASUREMENTS WERE OBSERVED WITH THE ARM MOVEMENT. A HEALTH CARE PROFESSIONAL (HCP) STATED THAT THRESHOLD MEASUREMENTS AND PACING IMPEDANCE MEASUREMENT HAVE BEEN STABLE. FURTHER, AN X-RAY WAS RECOMMENDED TO ASSESS THE LEAD. ATTEMPTS TO OBTAIN AN ADDITIONAL INFORMATION WERE UNSUCCESSFUL. THE SYSTEM REMAINS IN SERVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND RIGHT VENTRICULAR (RV) LEAD CONTINUED TO EXHIBIT ADDITIONAL HIGH OUT OF RANGE SHOCK IMPEDANCE MEASUREMENTS. A SYNCHRONOUS 1.1 JOULE SHOCK WAS DELIVERED TO TEST THE SYSTEM AND THE SHOCK IMPEDANCE WAS 76 OHMS. THE SYSTEM REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED INDICATING THIS IMPLANTABLE DEFIBRILLATION LEAD WAS LATER SURGICALLY ABANDONED. A SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (S-ICD) SYSTEM WAS IMPLANTED ALONG WITH A CONCOMITANT PACEMAKER. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400130 ENDOTAK RELIANCE G IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS BOSTON SCIENTIFIC CORPORATION 0184

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| L| R 4047| N118| N051| H175| 4087| 0184| 4592| 4517