BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALTRUA

    MDR report key: 3213085 · Received July 9, 2013

    Report

    Report Number
    2124215-2013-10401
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 19, 2013
    Report Date
    October 22, 2013
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT TO THE POST MARKET QUALITY ASSURANCE LABORATORY, ANALYSIS WILL BE PERFORMED AND THIS EVENT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    - -

    Additional Manufacturer Narrative · 1

    UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS PERFORMED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. THE DEVICE WAS THEN EXPOSED TO SIMULATED HEART LOAD CONDITIONS, AND THE DEFIBRILLATION, PACING AND SENSING FUNCTIONS WERE TESTED. THE DEVICE OPERATED APPROPRIATELY, ACCORDING TO ITS PERFORMANCE SPECIFICATIONS, WITH NO INTERRUPTIONS IN THERAPY OUTPUT OR PROGRAMMER COMMUNICATION AT THE RETURNED PROGRAMMED SETTINGS. A SERIES OF ELECTRICAL TESTS WAS ALSO PERFORMED, AND AGAIN, NORMAL DEVICE FUNCTION WAS OBSERVED. ANALYSIS CONCLUDED THIS DEVICE MET SPECIFICATION.

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    - -

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE AND NON-BOSTON SCIENTIFIC RIGHT VENTRICULAR LEAD WAS BROUGHT TO THE HOSPITAL AFTER EXPERIENCING A SYNCOPAL EPISODE WITH HEAD INJURIES. DEVICE INTERROGATION REVEALED AN VENTRICULAR TACHYCARDIA EPISODE IN THE ARRHYTHMIA LOGBOOK CAUSED BY NON-CAPTURE. IT WAS DETERMINED THIS WAS NOT A TRUE VENTRICULAR TACHYCARDIA EPISODE. ATTEMPTS TO REPRODUCE NOISE WERE UNSUCCESSFUL. IMPEDANCE AND THRESHOLD MEASUREMENTS WERE WITHIN NORMAL RANGE. THE DEVICE OUTPUT SETTINGS WERE REPROGRAMMED. A HOLTER MONITOR WAS APPLIED REVEALING PAUSES OF TWO TO THREE SECONDS WITHOUT A FURTHER SYNCOPAL EPISODE. THE DEVICE SENSITIVITY WAS REPROGRAMMED AND A FURTHER HOLTER WAS RECORDED REVEALING SIMILAR PAUSES AND QRS UNDERSENSING FOLLOWED BY THE RV STIMULATION. AN X-RAY DID NOT REVEAL THE RV LEAD WAS DISLODGED. AN INTERNAL TECHNICAL SERVICE CONSULTANT WAS CONTACTED FOR THEIR RECOMMENDATIONS. AS NO STIMULATION SPIKE WAS OBSERVED DURING THE PACING PAUSES, IT WAS DETERMINED THERE WERE OVERSENSED NON-CARDIAC SIGNALS; POSSIBLY ACUTE, HIGH AMPLITUDE NOISY SIGNALS. THESE MAY BE DUE TO METAL TO METAL CONTACT SUCH AS A PARTIAL LEAD ISSUE OR LEAD INSULATION DEFECT DUE TO THE LEAD CONDUCTOR NOT INSULATED AND CONTACT MAY GENERATE ARTIFICIAL POTENTIALS. FURTHER DISCUSSION WAS RECOMMENDED WITH THE PHYSICIAN. IT WAS THOUGHT THE ISSUE WAS LEAD RELATED, HOWEVER THE REASON COULD NOT BE DETERMINED AT THIS TIME. IN ADDITION, ENGINEERING REVIEWED THE DATA AND FOUND NO RESETS OR MEMORY ERRORS IN THE DEVICE. A PROCEDURE WAS PERFORMED. WHEN THE POCKET WAS OPENED, NO VISUAL ISSUE WAS NOTED WITH THE SET SCREWS. THE NON-BOSTON SCIENTIFIC LEAD WAS MOVED WITHOUT CREATING NOISE. HOWEVER A MISSING SPIKE WAS OBSERVED ON PACEMAKER. DURING PROCEDURE, A MISSING SPIKE WAS OBSERVED ON THE ECG WHILE THE DEVICE WAS PROGRAMMED IN DOO PACING MODE. A DECISION WAS MADE TO REPLACE THIS DEVICE AND THE LEAD. THE DEVICE WILL BE RETURNED FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312175 ALTRUA IMPLANTABLE PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND S603

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R