BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COGNIS

    MDR report key: 2911790 · Received January 11, 2013

    Report

    Report Number
    2124215-2012-17283
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 6, 2012
    Report Date
    August 21, 2017
    Manufacturer
    GUIDANT CRM CLONMEL IRELAND
    Product Code
    LWP
    PMA / PMN Number
    P010012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI
    Reporter Occupation
    PATIENT

    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.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE PRODUCT HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED, ANALYSIS WILL BE PERFORMED AND THIS REPORT WOULD BE UPDATED AT THAT TIME.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) WAS DEPLETING FASTER THAN EXPECTED. IT WAS ALSO REPORTED THAT THE PATIENT HAD BEEN FEELING VIBRATIONS COMING FROM THEIR BODY. AT THIS TIME, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATES THAT THE PATIENT WITH THIS CRT-D UNDERWENT A SURGICAL PROCEDURE AND THIS PRODUCT WAS EXPLANTED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18806 COGNIS IMPLANTABLE CHF PULSE GENERATOR LWP GUIDANT CRM CLONMEL IRELAND N119

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| L| R H210| MISMATCH| 4542| N119| 4543| 0184| (B)(4)| 4472| 4549| 294-23E