BEUDAMED
    FDA Adverse Event Death Summary report: N

    INGEVITY

    MDR report key: 7185070 · Received January 11, 2018

    Report

    Report Number
    2124215-2018-00834
    Event Type
    Death
    Date Received
    January 11, 2018
    Date of Event
    January 3, 2018
    Report Date
    January 4, 2018
    Manufacturer
    CPI - DEL CARIBE
    Product Code
    LWP
    UDI-DI
    00802526523335
    PMA / PMN Number
    P150012/S000
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 PACEMAKER PASSED AWAY THE EVENING AFTER THE PACEMAKER WAS IMPLANTED. THE IMPLANT PROCEDURE WAS UNREMARKABLE OTHER THAN THE RIGHT VENTRICULAR (RV) LEAD BEING REPOSITIONED ONCE RESULTING IN GOOD LEAD MEASUREMENTS. THE PATIENT HAD ATRIAL FIBRILLATION (AF) AND WAS NOT PACEMAKER DEPENDENT. THE PATIENT WAS DISCHARGED HOME RIGHT AFTER THE IMPLANT AND WAS SYNCOPAL. EMERGENCY MEDICAL SERVICES WERE CONTACTED AND RESUSCITATION EFFORTS WERE GIVEN BETWEEN 45-60 MINUTES. A REMOTE MONITORING INTERROGATION WAS PERFORMED, WHICH SHOWED THE PATIENT WENT INTO VENTRICULAR TACHYCARDIA (VT), THEN WENT INTO VENTRICULAR FIBRILLATION (VF). OTHER THAN A DROP IN R-WAVE AMPLITUDES FROM 13-16.2MV DOWN TO 3.2MV, ALL OTHER LEAD VALUES LOOKED NORMAL UPON REVIEWING THE REMOTE MONITORING TRANSMISSION. INDICATIONS FOR THE PACEMAKER IMPLANT WERE CHRONIC ATRIAL FIBRILLATION (AF), SO THE PATIENT RECEIVED A SINGLE CHAMBER PACEMAKER FOR THAT REASON. ALL OTHER LEAD VALUES LOOKED NORMAL UPON REVIEWING THE REMOTE MONITORING TRANSMISSION. THE FIELD REPRESENTATIVE DID NOT KNOW IF THE DEVICE WOULD BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26955 INGEVITY IMPLANTABLE LEAD LWP CPI - DEL CARIBE 7732 00802526523335

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death| L