BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE SENSE LEAD MRI SURESCAN

    MDR report key: 23184865 · Received September 30, 2025

    Report

    Report Number
    2649622-2025-27389
    Event Type
    Injury
    Date Received
    September 30, 2025
    Date of Event
    August 5, 2025
    Report Date
    September 30, 2025
    Manufacturer
    MEDTRONIC PUERTO RICO VILLALBA
    Product Code
    DTB
    PMA / PMN Number
    P830061
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: DTPB2QQ CRT-D IMPLANTED: (B)(6) 2025. 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 BY THE PATIENT THAT THEIR CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) HAD ¿BEEN BUGGING ME EVER SINCE I GOT IT. IT GIVES ME A LITTLE ZZZ EVERY ONCE IN A WHILE, IT FEELS LIKE IT¿S POKING ME UNDER MY ARM.¿ THE PATIENT NOTED WANTING TO TAKE THE DEVICE OUT AND PUT IT BACK IN CORRECTLY. THE PATIENT NOTED IT WAS ¿KIND OF LUMPY AND HAS A TENDER SPOT.¿ FOLLOW UP WITH THE CLINIC INDICATED THAT IT WAS DOUBTFUL THE PATIENT¿S REPORTED SYMPTOMS WERE RELATED TO A PRODUCT PERFORMANCE ISSUE, BUT THEY COULD NOT RULE OUT LEFT VENTRICULAR (LV) LEAD STIMULATION. IT WAS NOTED THAT THE PATIENT WAS SEEN WITH SIMILAR SYMPTOMS, AND THE REPORTED SIGNS AND SYMPTOMS PERSISTED EVEN WHEN THE LV LEAD WAS TEMPORARILY SHUT OFF. IT WAS ALSO NOTED THAT THERE WAS NO INDICATION THAT THE DEVICE SYSTEM WAS INCORRECTLY IMPLANTED. THE ROOT CAUSE OF THE SYMPTOMS WAS NOT IDENTIFIED, BUT IT WAS NOTED THAT THE PATIENT HAD MULTIPLE BACK PROCEDURES PERFORMED. THE CRT-D AND LV LEAD REMAIN IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2154223 CAPSURE SENSE LEAD MRI SURESCAN PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC PUERTO RICO VILLALBA 457453

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention 6935M62 LEAD, 457453 LEAD.