BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 4676175 · Received April 9, 2015

    Report

    Report Number
    2182208-2015-00893
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    January 1, 2014
    Report Date
    February 11, 2015
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    PMA / PMN Number
    P930029
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    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. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REFERENCED ARTICLE: INFLUENCE OF LEFT ATRIAL SIZE ON THE OUTCOME OF PULMONARY VEIN ISOLATION IN PATIENTS WITH ATRIAL FIBRILLATION. KARDIOLOGIA POLSKA. 2014;72(11):1135-1140. (B)(4).

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING A PULMONARY VEIN ISOLATION (PVI) PROCEDURE WHICH WAS COMPLICATED WITH CARDIAC PERFORATION AND SUBSEQUENT CARDIAC TAMPONADE. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL DETAILS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236236 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-EP-CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R