BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2913692 · Received January 14, 2013

    Report

    Report Number
    2124215-2013-00480
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    June 25, 2012
    Report Date
    February 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LWP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT DURING A RECENT INTERROGATION, THIS DEVICE EXHIBITED A FAULT CODE INDICATIVE OF LOW BATTERY VOLTAGE FOR THE SUSPECTED REMAINING CAPACITY. THE DEVICE HISTORY WAS THEN SENT FOR REVIEW AT WHICH TIME ENGINEERS CONFIRMED THE DEVICE WAS MALFUNCTIONING AND SHOULD BE SCHEDULED FOR REPLACEMENT. NO ADVERSE PATIENT EFFECTS WERE REPORTED AND NO DATE FOR REPLACEMENT HAS BEEN CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19973 COGNIS IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION P106 000389
    19974 COGNIS IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) LWP BOSTON SCIENTIFIC CORPORATION P106 000389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| L| R