BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2812355 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-17428
    Event Type
    Injury
    Date Received
    October 31, 2012
    Date of Event
    October 19, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024/S2
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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: (B)(4) - THE FULL LEAD WAS RETURNED, ANALYZED AND THE OUTER INSULATION WAS TORN. IT WAS NOTED THAT THE LEAD APPEARED TO HAVE BEEN DAMAGED AT IMPLANT. IT WAS VISUALLY NOTED THAT THE INSULATION AROUND THE SUTURE HOLES IS TORN. APPEARS TO BE DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE PHYSICIAN NOTICED A SMALL INSULATION BREAK NEAR THE ELECTRODE. THE LEAD WAS NOT USED AND A DIFFERENT LEAD WAS IMPLANTED. THERE WAS NO PATIENT COMPLICATIONS 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

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other