BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PASSIVE PLUS, DXZ, PKGD/STER

    MDR report key: 9336376 · Received November 18, 2019

    Report

    Report Number
    2017865-2019-16614
    Event Type
    Injury
    Date Received
    November 18, 2019
    Date of Event
    October 7, 2019
    Report Date
    March 30, 2020
    Manufacturer
    ABBOTT
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED.

    Additional Manufacturer Narrative · 1

    FURTHER INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Description of Event or Problem · 1

    DURING FOLLOW-UP, OVERSENSING DUE TO NOISE WAS NOTED ON THE RIGHT VENTRICULAR AND RIGHT ATRIAL LEADS. A REVISION PROCEDURE IS ANTICIPATED BUT NOT YET SCHEDULED. THE PATIENT WAS IN STABLE CONDITION. RELATED TO MANUFACTURER REPORT NUMBER: 2017865-2019-16610.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE EVENT WAS RESOLVED BY REVISING THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS. FURTHER INFORMATION WAS REQUESTED BUT NOT AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THE EVENT WAS RESOLVED BY CAPPING AND REPLACING THE RIGHT ATRIAL AND RIGHT VENTRICULAR LEADS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1131238 PASSIVE PLUS, DXZ, PKGD/STER PERMANENT PACEMAKER ELECTRODE DTB ABBOTT 1446

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R