BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 2780016 · Received October 10, 2012

    Report

    Report Number
    2124215-2012-12039
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 7, 2012
    Report Date
    August 2, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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.

    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 THIS RIGHT VENTRICULAR (RV) LEAD EXHIBITED OUT OF RANGE PACING LEAD IMPEDANCES GREATER THAN 2,000 OHMS. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PHYSICIAN WILL CONTINUE TO FOLLOW THIS PATIENT CLOSELY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THIS PRODUCT CONTINUES TO EXHIBIT OUT OF RANGE PACING IMPEDANCE AND NOW THE SYSTEM HAS DETECTED AN OUT OF RANGE SHOCK IMPEDANCE. IT WAS REPORTED THAT THE PHYSICIAN PLANS TO CONTINUE TO MONITOR THIS PATIENT AT THIS TIME.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE CLINIC PLANS TO SCHEDULE AN APPOINTMENT WITH THE PATIENT AND THE DEVICE NURSE WILL PERFORM THE EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS RIGHT VENTRICULAR (RV) DEFIBRILLATION LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) CONTINUED TO EXHIBIT HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENTS GREATER THAN 2,000 OHMS. AN INVASIVE PROCEDURE WAS PERFORMED. THE PACE/SENSE PORTION OF THE RV LEAD WAS SURGICALLY ABANDONED AND A NEW RV PACE/SENSE LEAD WAS IMPLANTED. THE SHOCK PORTION OF THE RV DEFIBRILLATION LEAD REMAINS IN SERVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THIS PRODUCT REMAINS IMPLANTED AND IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS BOSTON SCIENTIFIC CORPORATION 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| L| R 4036| 0147| T125| E110