BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2130698 · Received June 16, 2011

    Report

    Report Number
    2182208-2011-00872
    Event Type
    Injury
    Date Received
    June 16, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY FOR (B)(4): THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. ADDITIONAL FINDING OF A SET SCREW MISSING PART.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ATRIAL LEAD WAS FAR-FIELD R-WAVE OVERSENSING AND THE VENTRICULAR LEAD HAD HIGH THRESHOLD. DURING REPLACEMENT OF THE LEADS THE DEVICE SET SCREW "FELL OUT" OF THE DEVICE. WHILE ATTEMPTING TO REPOSITION THE SET SCREW, THE GROMMET AND SET SCREW WERE STRIPPED. THE DEVICE WAS EXPLANTED AND REPLACED. THE LEADS WERE CAPPED AND REPLACED. NO PATIENT COMPLICATIONS WERE 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 44 YR Hospitalization| R