BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBALT¿ DR MRI SURESCAN¿

    MDR report key: 19351585 · Received May 20, 2024

    Report

    Report Number
    9614453-2024-01985
    Event Type
    Injury
    Date Received
    May 20, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 20, 2024
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    LWS
    UDI-DI
    00763000178376
    PMA / PMN Number
    P980016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: 0180 BOSTON SCIENTIFIC LEAD IMPLANTED: (B)(6) 2011. 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 NOTICED THAT THEIR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) HAD MIGRATED TO THEIR LEFT BREAST. THE PATIENT WAS BROUGHT IN FOR A POCKET REVISION, WHICH LEAD TO THE DISCOVERY OF POCKET INFECTION, WITH VISIBLE PUSS AND DISCOLOREDTISSUE. THE ENTIRE SYSTEM WAS EXPLANTED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1162535 COBALT¿ DR MRI SURESCAN¿ IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) LWS MEDTRONIC EUROPE SARL DDPB3D1 00763000178376

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Female Required Intervention| H 407652 LEAD, 407645 LEAD.