BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITALIO

    MDR report key: 4131654 · Received October 1, 2014

    Report

    Report Number
    2124215-2014-13878
    Event Type
    Injury
    Date Received
    October 1, 2014
    Date of Event
    July 4, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INVESTIGATION INTO THIS ISSUE IS CURRENTLY ONGOING. ONCE ANY ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS REPORT WILL BE UPDATED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER HAD RECORDED EPISODES DUE TO NOISE THAT WAS BEING OVERSENSED. BOSTON SCIENTIFIC TECHNICAL SERVICES (TS) WAS CONTACTED AND REQUESTED TO REVIEW THE DATA FROM THE PATIENT¿S REMOTE MONITORING SYSTEM. A TS CONSULTANT REVIEWED THE DATA AND DISCUSSED THAT THE NOISE WAS AT A CONSISTENT 20 HZ; HOWEVER, THE DEVICE WAS STILL PACING AT 50 BPM WITHIN THE NOISE WINDOW. THE NOISE WAS CONSISTENT WITH RESPIRATORY RATE TREND OVERSENSING AND THE TS CONSULTANT DISCUSSED SWITCHING THIS FEATURE OFF AND THEN BACK ON TO PERFORM FURTHER TESTING TO INVESTIGATE THE POTENTIAL SOURCE OF THE NOISE. IT WAS ALSO DISCUSSED THAT THE PACING IMPEDANCE MEASUREMENTS HAD SUDDENLY INCREASED IN THE PAST FEW DAYS FOR FURTHER EVALUATION OF THE LEAD AND DEVICE WAS STRONGLY SUGGESTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. SEVERAL DAYS LATER, A HIGH OUT OF RANGE PACING IMPEDANCE MEASUREMENT WAS DETECTED BY THIS DEVICE WHICH TRIGGERED A LEAD SAFETY SWITCH TO UNIPOLAR MODE. TS WAS CONTACTED AGAIN AND CONFIRMED THAT A PACING IMPEDANCE MEASUREMENT ABOVE 2,000 OHMS WAS RECORDED WHICH TRIGGERED THE SAFETY SWITCH. THE TS CONSULTANT DISCUSSED THAT THE SYSTEM INTEGRITY SHOULD BE EVALUATED AS THERE IS A POSSIBLE OPEN CIRCUIT CONDITION. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THE LEAD INFORMATION WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    612575 VITALIO IMPLANTABLE PULSE GENERATOR LWP BOSTON SCIENTIFIC CORPORATION J275 101402

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Life Threatening| R| H J275| J275