BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACUITY SPIRAL

    MDR report key: 19681694 · Received July 5, 2024

    Report

    Report Number
    2124215-2024-41619
    Event Type
    Injury
    Date Received
    July 5, 2024
    Date of Event
    January 20, 2020
    Report Date
    July 29, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    PMA / PMN Number
    P010012/S160
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD THRESHOLD AND PACE IMPEDANCE MEASUREMENTS DOUBLED IN ABOUT 6 MONTHS. LEAD MEASUREMENTS WERE STILL IN RANGE. A CHEST X RAY WAS SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC). THIS LEAD HAD BEEN DEACTIVATED. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD SURGICALLY ABANDONED AND REPLACED DUE TO A LEAD FRACTURE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD THRESHOLD AND PACE IMPEDANCE MEASUREMENTS DOUBLED IN ABOUT 6 MONTHS. LEAD MEASUREMENTS WERE STILL IN RANGE. A CHEST X RAY WAS SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC). ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD HAD BEEN DEACTIVATED. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD THRESHOLD AND PACE IMPEDANCE MEASUREMENTS DOUBLED IN ABOUT 6 MONTHS. LEAD MEASUREMENTS WERE STILL IN RANGE. A CHEST X RAY WAS SCHEDULED. FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS LEFT VENTRICULAR (LV) LEAD THRESHOLD AND PACE IMPEDANCE MEASUREMENTS DOUBLED IN ABOUT 6 MONTHS. LEAD MEASUREMENTS WERE STILL IN RANGE. A CHEST X RAY WAS SCHEDULED. ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD EXHIBITED HIGH OUT OF RANGE PACE IMPEDANCE MEASUREMENTS AND LOSS OF CAPTURE (LOC). FURTHER INFORMATION WAS RECEIVED THAT THIS LEAD SURGICALLY ABANDONED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    930798 ACUITY SPIRAL IMPLANTABLE LEAD LWP BOSTON SCIENTIFIC CORPORATION 4592

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Male Hospitalization| R