BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2182208-2017-00695

    MDR report key: 6565353 · Received May 12, 2017

    Report

    Report Number
    2182208-2017-00695
    Event Type
    Injury
    Date Received
    May 12, 2017
    Date of Event
    September 28, 2016
    Report Date
    April 14, 2017
    Product Code
    GEH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE OF THE PATIENTS REPRESENTED IN THE ARTICLE IS MALE/(B)(6). WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE AND PMA/510K CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: EFFICACY AND SAFETY OF THE SECOND-GENERATION CRYOBALLOONS VERSUS RADIOFREQUENCY ABLATION FOR THE TREATMENT OF PAROXYSMAL ATRIAL FIBRILLATION: A SYSTEMATIC REVIEW AND META-ANALYSIS. 2017. SPRINGER SCIENCE+BUSINESS MEDIA. 2017; 48: 69-79.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A JOURNAL ARTICLE WAS REVIEWED WHICH CONTAINED INFORMATION REGARDING CRYOBALLOONS. MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITH UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THERE WERE PATIENTS WHO EXPERIENCED PHRENIC NERVE PALSY (PNP) AND PERICARDIAL TAMPONADE. THE STATUS/LOCATION OF THE CRYOBALLOON IS UNKNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344545 GEH CRYO-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Life Threatening