BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1780415 · Received August 3, 2010

    Report

    Report Number
    2649622-2010-06900
    Event Type
    Malfunction
    Date Received
    August 3, 2010
    Date of Event
    May 14, 2010
    Report Date
    September 24, 2024
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    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. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED FOR ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, AT IMPLANT, THERE WAS THRESHOLD VARIATION AND HIGH IMPEDANCE. THE LEAD WAS EXAMINED AND FLUID WAS DISCOVERED UNDER THE CATHODE, OR POSSIBLY THE ANODE. IT WAS ALSO REPORTED THAT THE MECHANISM WHERE THE ELECTRODE IS SEWN LOOKED LOOSE. 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 PUERTO RICO, INC. 4968 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other