BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ XT VR MRI SURESCAN¿

    MDR report key: 20942590 · Received December 16, 2024

    Report

    Report Number
    9614453-2024-04943
    Event Type
    Injury
    Date Received
    December 16, 2024
    Date of Event
    October 25, 2024
    Report Date
    December 16, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PRODUCT ID 6935M62 (TDL598425V); PRODUCT TYPE: 0264-LEAD-HV; IMPLANT DATE (B)(6) 2023; EXPLANT DATE (B)(6) 202014. 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

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED WITH CHEST PAIN. IT WAS NOTED THAT THE PATIENT SUFFERED A RECENT FINGER INJURY FOLLOWED BY FEVER. AN INFECTION WAS SUSPECTED AS A LARGE MASS OF VEGETATION WAS OBSERVED ATTACHED TO THE RIGHT VENTRICULAR (RV) LEAD. CULTURES WERE TAKEN AND ORGANISM WAS CONFIRMED TO BE STAPHYLOCOCCUS CAPITIS BACTEREMIA. ANTIBIOTICS WERE ADMINISTERED AND THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) SYSTEM WAS EXPLANTED AND REPLACED WITH A EXTRAVASCULAR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (EV-ICD) SYSTEM. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2375289 COBALT¿ XT VR MRI SURESCAN¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DVPA2D4

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Required Intervention| H SEE H11...