BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 1820520 · Received August 31, 2010

    Report

    Report Number
    2182208-2010-00607
    Event Type
    Injury
    Date Received
    August 31, 2010
    Date of Event
    May 7, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    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) NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT'S ABDOMEN WAS "HURTING". SURGERY WAS BEGUN WITH THE INTENTION OF MOVING THE DEVICE WITH LEAD EXTENDERS. TESTING DURING THE SURGERY FOUND THAT THE VENTRICULAR LEAD WAS STIMULATING THE MUSCLE. THE DEVICE, WHICH WAS ABDOMINALLY IMPLANTED, WAS REMOVED AND REPLACED WITH A DEVICE IN THE LEFT PECTORAL REGION, AND THE VENTRICULAR EPICARDIAL LEAD WAS CAPPED AND REPLACED. NO FURTHER 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. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Required Intervention 4965 IMPLANTABLE PACING LEAD