BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENDOTAK RELIANCE

    MDR report key: 3210043 · Received July 8, 2013

    Report

    Report Number
    2124215-2013-06705
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    April 13, 2013
    Report Date
    April 15, 2013
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS REQUESTED. 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 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) AND RIGHT VENTRICULAR (RV) LEAD CAUSED A RED ALERT TO BE DECLARED DUE TO HIGH SHOCK LEAD IMPEDANCES. THE PATIENT'S PHYSICAN IS AWARE OF THE SITUATION AND THE PACING SYSTEM REMAINS IMPLANTED AT THIS TIME. THE PATIENT WILL BE MONITORED CLOSELY. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THAT INCREASED PACING THRESHOLD MEASUREMENTS WERE OBSERVED. REGULAR FOLLOW UP WILL BE CONTINUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT WITH THIS RIGHT VENTRICULAR (RV) LEAD ATTENDED A FOLLOW UP VISIT AND SHOCK IMPEDANCES WERE FOUND TO BE WITHIN NORMAL RANGE. THE PREVIOUS OUT OF RANGE MEASUREMENT WAS CONSIDERED TO BE AN ISOLATED EPISODE AND THE PHYSICIAN IS NOT CONCERNED WITH THE HIGH SHOCK IMPEDANCES PREVIOUSLY FOUND. THE PATIENT WILL ATTEND NORMAL FOLLOW-UPS AND CONTINUED TO BE MONITORED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD AND DEVICE CONTINUED TO EXHIBIT HIGH SHOCK LEAD IMPEDANCES. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD REMAINS IN SERVICE.

    Description of Event or Problem · 1

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    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309198 ENDOTAK RELIANCE IMPLANTABLE LEAD LWS CPI - DEL CARIBE 0175

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening