BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSULTA CRT-D

    MDR report key: 2952353 · Received February 9, 2013

    Report

    Report Number
    3004209178-2013-01711
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    November 13, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    NIK
    PMA / PMN Number
    P010031/S084
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4). CONCOMITANT PRODUCT: (B)(4) IMPLANTABLE PACING LEAD (B)(6) 2007. ADDITIONAL INFORMATION INDICATES THE PATIENT HAD 'POSSIBLE PNEUMONIA.'

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A POCKET INFECTION DUE TO STAPHYLOCOCCUS AUREUS WITH POSSIBLE LEAD VEGETATION. THE 'FULL SYSTEM' WAS REMOVED. THERE WERE NO DEVICE OR LEAD PERFORMANCE ISSUES. PER THE PHYSICIAN'S MEDICAL REPORT THE PATIENT ALSO EXPERIENCED SEPSIS AND ENDOCARDITIS; TRANSESOPHAGEAL ECHOGRAM 'DEMONSTRATE[D]' 'POSSIBLE AORTIC VALVE VEGETATION AND A PROBABLE MITRAL VALVE VEGETATION,' THREE-PLUS MITRAL REGURGITATION AND TWO-PLUS AORTIC INSUFFICIENCY; PUS WAS COMING FROM THE DEVICE SITE. THE PHYSICIAN NOTED "A VERY HIGH SUSPICION THAT [THE PATIENT'S] PACEMAKER SITE IT IS PARTLY IF NOT FULLY RESPONSIBLE FOR [THE PATIENT'S] MOST RECENT COURSE." THE EXPLANTED SYSTEM WAS NOT RETURNED TO THE MANUFACTURER; ITS DISPOSITION IS UNKNOWN. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56833 CONSULTA CRT-D DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO NIK MEDTRONIC MED REL MEDTRONIC PUERTO RICO D224TRK

    Patients

    Seq Age Sex Outcome Treatment
    1 00082 YR Hospitalization| L| R (B)(4) IMPLANTABLE TACHY LEAD