BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2951981 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00339
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "REPEATED MASSIVE PULMONARY AIR EMBOLISM DURING PACEMAKER IMPLANTATION." INTERACT. CARDIOVASC. THORAC. SURG. DECEMBER 1 2012;15(6):1085-1087.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THESE LEADS. DURING THE IMPLANT PROCEDURE, THE PATIENT EXPERIENCED TWO PULMONARY AIR EMBOLISMS (PAE). THE PAES WERE RESOLVED AND THE PATIENT WAS DISCHARGED FROM THE HOSPITAL UNEVENTFULLY. THE LEADS REMAIN IN USE. ADDITIONAL INFORMATION OBTAINED THROUGH FOLLOW UP INDICATED THAT THERE WERE NO ALLEGATIONS AGAINST THE LEADS' PERFORMANCE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56859 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Hospitalization| R