BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PULSE-GENERATOR, PACEMAKER, IMPLANTABLE

    MDR report key: 8475104 · Received April 2, 2019

    Report

    Report Number
    2182208-2019-00630
    Event Type
    Injury
    Date Received
    April 2, 2019
    Date of Event
    November 20, 2018
    Report Date
    April 5, 2019
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. 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. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE TO ONE CORRELATION COULD NOT BE MADE WITHOUT UNIQUE MANUFACTURER/DEVICE SERIAL NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTIC IS MALE/50 YEARS OLD. A REQUEST FOR ADDITIONAL INFORMATION WILL BE MADE AND UPON RECEIPT A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: APPROACH, TECHNICAL SUCCESS, COMPLICATIONS, AND STENT PATENCY OF SHARP RECANALIZATION FOR THE TREATMENT OF CHRONIC VENOUS OCCLUSIVE DISEASE: EXPERIENCE IN 123 PATIENTS CARDIOVASCULAR INTERVENTIONAL RADIOLOGY 42(2):205-212 DOI.ORG/10.1007/S00270-018-2090-1. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    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 THAT CONTAINED INFORMATION REGARDING A TRANS-SEPTAL NEEDLE. THE AUTHORS DESCRIBED COMPLICATIONS THAT OCCURRED WHEN THE PATIENT¿S UNDERWENT RECANALIZATION OF CHRONIC VENOUS OCCLUSIONS. THERE WAS A CASE OF PERICARDIAL TAMPONADE, A CASE OF PERFORATION OF THE RIGHT BRACHIOCEPHALIC VEIN WHICH RESULTED IN HEMOTHORAX AND UNCOMPLICATED PLACEMENT OF A CHEST TUBE. ADDITIONALLY, THERE WAS A CASE OF SELF-LIMITED RETROPERITONEAL EXTRAVASATION AND A CASE OF SELF-CONTAINED EXTRAVASATION INTO THE MEDIASTINUM, PELVIS, AND LEFT UPPER ARM. THE STATUS/DISPOSITION OF THE TRANS-SEPTAL NEEDLE IS NOT KNOWN. FURTHER FOLLOW UP DID NOT YET YIELD ANY ADDITIONAL INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. THE REPORTED ADVERSE EVENTS WERE NOT ASSOCIATED WITH THE MANUFACTURERS TRANS-SEPTAL NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269049 PULSE-GENERATOR, PACEMAKER, IMPLANTABLE DXY MEDTRONIC, INC. MDT-UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| L| R