BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INGENIO

    MDR report key: 8324485 · Received February 9, 2019

    Report

    Report Number
    2124215-2018-64398
    Event Type
    Injury
    Date Received
    February 9, 2019
    Date of Event
    November 16, 2018
    Report Date
    February 9, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION HAS BEEN PROVIDED TO DATE. THIS REPORT WILL BE UPDATED SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IMPLANTED WITH THIS DEVICE WAS FOUND WITH A HEART RATE OF 40 BPM. UPON INTERROGATION, A CODE 1003 INDICATIVE OF BATTERY VOLTAGE TOO LOW FOR THE PROJECTED REMAINING CAPACITY WAS OBSERVED. DEVICE REPLACEMENT WAS RECOMMENDED. THIS DEVICE REMAINS IN SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117479 INGENIO PULSE-GENERATOR, SINGLE CHAMBER, SINGLE LWW BOSTON SCIENTIFIC CORPORATION J172 295471

    Patients

    Seq Age Sex Outcome Treatment
    1