BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3050135 · Received April 10, 2013

    Report

    Report Number
    2124215-2013-04567
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    February 20, 2013
    Report Date
    September 18, 2016
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS CURRENTLY AVAILABLE, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    FURTHER INFORMATION WAS RECEIVED THAT THE PHYSICIAN WAS NOTIFIED OF THE OOR IMPEDANCE READING AND THE DEVICE WILL BE CHECKED AT THE NEXT ROUTINE FOLLOW-UP APPOINTMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT CONTACTED BOSTON SCIENTIFIC PATIENT SERVICES AS THE REMOTE HOME MONITORING SYSTEM HAD A RED BLINKING LIGHT WITH A CODE. REVIEW OF THE CODE INDICATED THAT THE RIGHT VENTRICULAR (RV) LEAD IMPEDANCE WAS HIGH AND OUT OF RANGE. PATIENT SERVICES ASSISTED THE PATIENT WITH COMPLETING A SUCCESSFUL REMOTE INTERROGATION AND THE PATIENT WAS REFERRED TO THEIR CLINIC. AT THIS TIME THE RV LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REMAIN IN SERVICE AND NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PATIENT'S HOME MONITORING SYSTEM DETECTED A HIGH, OUT-OF-RANGE (OOR), PACING IMPEDANCE FOR THIS RIGHT VENTRICULAR (RV) LEAD AND IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM. AT THIS TIME, NO ADVERSE PATIENT EFFECTS WERE REPORTED AND ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE FIELD REPRESENTATIVE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149572 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0147

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR E110| A155| 4086