BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPRINT QUATTRO SECURE

    MDR report key: 2952460 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00569
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 2, 2012
    Report Date
    November 2, 2012
    Manufacturer
    MPRI
    Product Code
    LWS
    PMA / PMN Number
    P920015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, 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).

    Description of Event or Problem · 1

    IT WAS REPORTED AN INFECTION OCCURRED. APPROXIMATELY FOUR WEEKS POST IMPLANT, THE PATIENT NOTICED THE POCKET SITE WAS REDDENED AND DRAINAGE WAS PRESENT. THE PATIENT WAS PLACED ON ORAL ANTIBIOTICS. THE POCKET SITE OPENED TWO DAYS LATER. POCKET CULTURE WAS POSITIVE FOR 'NORMAL SKIN FLORA.' THE LEAD TIP CULTURE WAS POSITIVE FOR COAGULASE NEGATIVE STAPH 'LIKELY CONTAMINATED UPON REMOVAL FROM VEIN THROUGH' THE POCKET. THE LEAD WAS REMOVED AND REPLACED AND THE PATIENT WAS PLACED ON INTRAVENOUS ANTIBIOTICS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    55857 SPRINT QUATTRO SECURE DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER LWS MPRI 6935M62

    Patients

    Seq Age Sex Outcome Treatment
    1 00042 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIAC DEFIBRILLATOR