BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INGENIO

    MDR report key: 2910840 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-16455
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Date of Event
    November 17, 2012
    Report Date
    November 17, 2012
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    NVZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, AT THIS TIME THERE IS NO FURTHER INFORMATION AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE THIS REPORT WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE LOCAL AREA SALES REPRESENTATIVE INDICATED THAT THE ROOT CAUSE TO THE ISSUE WAS NEVER DETERMINED. THE RESULTS OF THE CHEST X-RAY INDICATED APPROPRIATE LEAD POSITION. THE SALES REPRESENTATIVE HAS NOT RECEIVED ANY FOLLOW UP CALLS FROM THE PHYSICIAN NOR THE PHYSICIAN'S OFFICE OUTLINING ANY CONCERNS REGARDING THIS PATIENT. THE PATIENT WAS ADVISED TO CONTACT THEIR PHYSICIAN IF THERE WERE EVER ANY ISSUES. 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

    --

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT ONE DAY POST IMPLANT THE PATIENT WITH THIS PACEMAKER EXPERIENCED A DECREASE IN THEIR HEART RATE TO 29-35 BEATS PER MINUTE (BPM) INTERMITTENTLY FOR APPROXIMATELY FORTY FIVE MINUTES. THE PATIENT WAS REPORTEDLY LYING FLAT ON THEIR BACK WHEN IT OCCURRED. IT HAD BEEN REPORTED THAT THE PATIENT WENT INTO COMPLETE HEART BLOCK DURING THE IMPLANT PROCEDURE. ALL PACING IMPEDANCE AND THRESHOLD MEASUREMENTS WERE TESTED AND WITHIN NORMAL LIMITS. VENTRICULAR TACHYCARDIA (VT) STORAGE IN THE DEVICE WAS ON AND THERE WERE NO EPISODES STORED IN THE ARRHYTHMIA LOGBOOK. HOWEVER, THERE WERE 247 PREMATURE VENTRICULAR CONTRACTIONS (PVC) AND THE PATIENT'S RATE COUNT WAS AS LOW AS 50-59 BPM TO AS HIGH AS 240-249 BPM. A BOSTON SCIENTIFIC TECHNICAL SERVICES CONSULTANT DISCUSSED THE ISSUE MAY BE RELATED TO THE PVC'S, LOSS OF CAPTURE (LOC), OR OVERSENSING OF NOISE. THE POSITION OF THE NEWLY IMPLANTED LEAD WAS ALSO IN QUESTION. THE LOCAL AREA SALES REPRESENTATIVE PLANNED TO DECREASE THE SENSITIVITY TO 3 MV AND OBTAIN A CHEST X-RAY. AT THIS TIME THE ROOT CAUSE OF THE ISSUE IS UNKNOWN. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17245 INGENIO IMPLANTABLE PULSE GENERATOR NVZ GUIDANT CRM CLONMEL IRELAND K063

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR 4136| 4135| K063