BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATTAIN ABILITY

    MDR report key: 3507432 · Received December 9, 2013

    Report

    Report Number
    2649622-2013-13774
    Event Type
    Injury
    Date Received
    December 9, 2013
    Date of Event
    January 1, 2012
    Report Date
    October 3, 2013
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    OJX
    PMA / PMN Number
    P080006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: EXTENSIVE ASYMPTOMATIC PULMONARY AIR EMBOLISM DURING CRT-IMPLANTATION. ACTA CARDIOL. 2012; 67(5):593-594. CONCOMITANT PRODUCT: CORONARY SINUS GUIDING SHEATH. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING THIS LEAD AND CORONARY SINUS GUIDING SHEATH. DURING THE PROCEDURE TO IMPLANT A CARDIAC RESYNCHRONISATION THERAPY (CRT) SYSTEM, WHILE TEARING THE INTRODUCER SHEATH, THE PATIENT TOOK A DEEP BREATH, AND WITH A "SNORING NOISE," AIR WAS "SUCKED" INTO THE VENOUS SYSTEM. A FLUOROSCOPY WAS PERFORMED IMMEDIATELY AND A LARGE AIR BUBBLE WAS SEEN "RIDING ON THE PULMONARY VALVE." THE AIR BUBBLE GRADUALLY DISAPPEARED DURING THE NEXT 15 MINUTES. THE PATIENT WAS OBSERVED FOR 24 HOURS WITHOUT ANY ISSUES. THE PATIENT WAS DISCHARGED TWO DAYS LATER WITHOUT ANY PERMANENT DAMAGE. THE LEAD APPEARS TO REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635979 ATTAIN ABILITY DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE OJX MEDTRONIC PUERTO RICO OPERATIONS CO. 4196

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R