BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ XT VR MRI SURESCAN¿

    MDR report key: 20882531 · Received December 9, 2024

    Report

    Report Number
    2182208-2024-05208
    Event Type
    Injury
    Date Received
    December 9, 2024
    Date of Event
    January 1, 2023
    Report Date
    December 9, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. MEDTRONIC WAS MADE AWARE OF THIS EVENT THROUGH A SEARCH OF LITERATURE PUBLICATIONS. OF NOTE, MULTIPLE PATIENTS AND MULTIPLE MANUFACTURERS WERE NOTED IN THE ARTICLE; HOWEVER, A ONE-TO-ONE CORRELATION COULD NOT BE MADE WITH UNIQUE PRODUCT SERIAL/LOT NUMBERS. THE BASELINE GENDER/AGE CHARACTERISTICS IS FEMALE/47 YEARS OLD. 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. A REQUEST FOR ADDITIONAL INFORMATION WAS MADE. IF ADDITIONAL INFORMATION IS OBTAINED REGARDING THIS EVENT, IT WILL BE ADDED, AND A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY. REFERENCED ARTICLE: INFLAMMATORY REACTION TO TYRX ANTIBACTERIAL ENVELOPE MIMICKING INFECTION. JOURNAL OF CARDIOVASCULAR ELECTROPHYSIOLOGY. 2023; 34:1755¿1757. DOI: 10.1111/JCE.15985 MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    LITERATURE WAS REVIEWED REGARDING ANTIBACTERIAL ABSORBABLE ENVELOPE USAGE MIMICKING INFECTION. THE AUTHORS DESCRIBED THREE PATIENTS WHO EXPERIENCED PURULENT, CULTURE-NEGATIVE DISCHARGE FROM DEVICE POCKETS AFTER THE USE OF AN ANTIBACTERIAL ABSORBABLE ENVELOPE AND INFECTION WAS SUSPECTED. THE FIRST PATIENT HAD PAIN AND SWELLING AROUND THE DEVICE POCKET APPROXIMATELY TWELVE DAYS POST IMPLANT WITH PROFUSE PINK AND CLOUDY DRAINAGE FROM A SMALL INCISION DEHISCENCE. INTRAVENOUS (IV) ANTIBIOTICS WERE ADMINISTERED, AND A DEVICE EXTRACTION WAS PERFORMED, AND THE DEVICE WAS NOT REPLACED. WOUND TISSUE AND LEAD CULTURE WERE NEGATIVE. ANOTHER PATIENT PRESENTED APPROXIMATELY SEVEN WEEKS POST IMPLANT REQUIRING A DEVICE UPGRADE. DURING THE PROCEDURE, COPIOUS YELLOWISH MILKY FLUID WAS NOTED WHEN THE DEVICE POCKET WAS OPENED. CULTURES OF THE POCKET TISSUE AND POCKET FLUID WERE NEGATIVE. THE THIRD PATIENT HAD PERSISTENT SECRETION OF TURBID SEROSANGUINOUS FLUID FROM A SMALL SKIN OPENING APPROXIMATELY TEN DAYS POST IMPLANT. ANTIBIOTICS WERE GIVEN FOR TEN DAYS WITHOUT RESOLUTION OF THE DRAINAGE. THE SKIN WAS CLOSED WITH TWO STITCHES ON DAY 16 AFTER THE IMPLANT. GRAM STAIN WAS NEGATIVE FOR THE ORGANISM, AND ONLY VERY LIGHT POLYMORPHONUCLEAR LEUKOCYTES WERE NOTED. FLUID FROM THE WOUND WAS CULTURE NEGATIVE. THE STATUS OF THE DEVICES IS UNKNOWN. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1504363 COBALT¿ XT VR MRI SURESCAN¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC, INC. DVPA1D4

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Female Hospitalization| R UNKNOWN LEAD