BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2124058 · Received June 14, 2011

    Report

    Report Number
    2182208-2011-01031
    Event Type
    Injury
    Date Received
    June 14, 2011
    Report Date
    March 5, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REGULAR FOLLOW UP THE VENTRICULAR THRESHOLDS WERE HIGH IN BOTH BIPOLAR AND UNIPOLAR MODES. A VENTRICULAR LEAD FRACTURE IS SUSPECTED. THE DEVICE WAS REPROGRAMMED. THE LEAD WILL REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE LEFT VENTRICULAR LEAD WAS ELECTRICALLY ABANDONED DURING THE REPROGRAMMING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING REGULAR FOLLOW UP THE VENTRICULAR THRESHOLDS WERE HIGH IN BOTH BIPOLAR AND UNIPOLAR MODES. A VENTRICULAR LEAD FRACTURE IS SUSPECTED. THE DEVICE WAS REPROGRAMMED. THE LEAD WILL REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR Male Required Intervention