BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 3953801 · Received July 23, 2014

    Report

    Report Number
    2124215-2014-14201
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 8, 2014
    Report Date
    June 8, 2014
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR
    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 THE PATIENT IMPLANTED WITH THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS IN VENTRICULAR TACHYCARDIA (VT). COMMANDED ANTI-TACHYCARDIA PACING (ATP) WAS ATTEMPTED BUT WAS INEFFECTIVE AND ACCELERATED THE RHYTHM. FURTHER THERAPY WAS DELIVERED BUT DID NOT CONVERT THE VT. THE PHYSICIAN ATTEMPTED COMMANDED SHOCKS BUT WAS UNABLE TO BECAUSE THE BUTTON WAS GRAYED OUT ON THE PROGRAMMER. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND DISCUSSED THE REASON WHY COMMANDED SHOCKS COULD NOT BE DELIVERED WAS BECAUSE THE DEVICE WAS PROGRAMMED TO MONITOR ONLY. THE DEVICE WAS REPROGRAMMED AND A COMMANDED SHOCK WAS THEN USED TO CONVERT THE PATIENT. SEVERAL DAYS LATER THE PATIENT HAD AN ABLATION PROCEDURE DUE TO SLOW VT. THE PHYSICIAN WAS QUESTIONING WHY THE PATIENT RECEIVED A SHOCK. TS REVIEWED ELECTROGRAM (EGM) AND NOTED THE DEVICE EXHAUSTED ALL ATP THERAPY PROGRAMMED AND DELIVERED A SHOCK. THERE WERE NO SHOCKS PROGRAMMED IN THE VT-1 ZONE SO NO OTHER THERAPY WAS DELIVERED. THE PATIENT IS NOT SYMPTOMATIC AND THERE WAS NO ADDITIONAL ADVERSE PATIENT EFFECTS REPORTED. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    431239 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R MISMATCH| 0155| T127| 4555| N119| 4464| 1851| E110