BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENTAK PRIZM 2

    MDR report key: 1771130 · Received July 27, 2010

    Report

    Report Number
    2124215-2010-12216
    Event Type
    Injury
    Date Received
    July 27, 2010
    Date of Event
    May 29, 2010
    Report Date
    June 11, 2010
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TS REPRESENTATIVE RE-REVIEWED THE ELECTROCARDIOGRAMS AND DISCUSSED THAT THERE WAS ATRIAL LOSS OF CAPTURE DURING POST-SHOCK PACING. THERE DID NOT APPEAR TO BE ANY UNDERSENSING BUT THERE WAS EVIDENCE OF FARFIELD SENSING OBSERVED ON THE ATRIAL CHANNEL. HOWEVER, THE FARFIELD SENSING DID NOT RESULT IN ANY OVERSENSING. IN ORDER TO CORRECT THE ATRIAL LOSS OF CAPTURE, THE TS REPRESENTATIVE SUGGESTED PERFORMING THRESHOLD TESTS AND TO INCREASE THE POST SHOCK PACING OUTPUT. AT THIS TIME, THIS ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION HAS BEEN REPORTED. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    A BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) REPRESENTATIVE REVIEWED THE DATA AND CONFIRMED THAT THE ICD INTERMITTENTLY UNDERSENSED THE VF DUE TO THE INTRINSIC EVENTS FALLING INTO THE VENTRICULAR BLANK FOLLOWING AN ATRIAL PACE REFRACTORY PERIOD. THE TIMING FOR THIS PERIOD IS NOMINALLY AT 65 MS AND MOST OF THE R-WAVES THAT WERE UNDERSENSED OCCURRED IN THE LAST 40 MS. THE TS REPRESENTATIVE DISCUSSED THAT IN ORDER TO REDUCE THE UNDERSENSING, REPROGRAMMING THE ICD TO 45 MS SHOULD BE CONSIDERED SO THAT THE VENTRICULAR BLANKING FOLLOWING THE ATRIAL PACE IS AS SHORT AS POSSIBLE. A REDUCTION IN THE ATRIAL BLANKING PERIOD WOULD NOT BE EFFECTIVE AS THIS ONLY AFFECTS THE ATRIAL CHANNEL. IT WAS ALSO DISCUSSED THAT CAPTURE IN THE VENTRICLE SHOULD BE EVALUATED AS THERE WAS A BEAT NOTED ON THE ELECTROCARDIOGRAM THAT DID NOT APPEAR TO BE CAPTURED ALTHOUGH THE MARKER INDICATED THERE WAS A VENTRICULAR PACE. AT THIS TIME, THIS ICD REMAINS IMPLANTED AND IN SERVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ANY ADDITIONAL INFORMATION DOES BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    AT A LATER DATE, IT WAS ASKED IF THE ATRIAL CHANNEL COULD BE EVALUATED AS IT APPEARED THERE MAY BE LOSS OF CAPTURE AND UNDERSENSING.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) EXPERIENCED SYNCOPE DURING AN EPISODE OF VENTRICULAR FIBRILLATION (VF). ONCE A SHOCK WAS DELIVERED, THE PATIENT REGAINED CONSCIOUSNESS. A REVIEW OF THE EPISODE REVEALED THAT THE VF WAS CORRECTLY DETECTED AND EFFECTIVELY CONVERTED THE ARRHYTHMIA WITH A 31 JOULE SHOCK. HOWEVER, THE ICD INITIALLY UNDERSENSED THE ARRHYTHMIA AS SOME OF THE BEATS WERE IN THE REFRACTORY PERIODS. THIS RESULTED IN THE DEVICE TO CONTINUE PACING IN DDDR MODE AT 120 BPM DURING THE ARRHYTHMIA AND DELAYING THERAPY DELIVERY. THE ICD WAS REPROGRAMMED TO REDUCE THE ATRIAL BLANKING PERIOD TO 45 MILLISECONDS (MS). PRINTOUTS OF THE EPISODES WERE PRINTED OUT AND SENT TO OUR INTERNAL TECHNICAL SERVICES FOR EVALUATION. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENTAK PRIZM 2 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS GUIDANT CRM CLONMEL IRELAND 1861

    Patients

    Seq Age Sex Outcome Treatment
    1