BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREEPI

    MDR report key: 3962090 · Received July 28, 2014

    Report

    Report Number
    2182208-2014-01872
    Event Type
    Injury
    Date Received
    July 28, 2014
    Date of Event
    November 27, 2013
    Report Date
    March 6, 2024
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    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 U.S. WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEADS DISPLAYED HIGH THRESHOLDS. THE LEADS WERE CAPPED AND REPLACED. THE PATIENT WAS ENROLLED IN THE (B)(4) STUDY (B)(4) TRIAL. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437591 CAPSUREEPI PERMANENT PACEMAKER ELECTRODE DTB MEDTRONIC, INC. 4968-35

    Patients

    Seq Age Sex Outcome Treatment
    1 11 YR Male Hospitalization| R 4968-35 LEAD, ADDR01 IPG| 4968-35 LEAD, ADDR01 IPG