BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSURE EPI

    MDR report key: 1822013 · Received September 1, 2010

    Report

    Report Number
    2182208-2010-00612
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 5, 2010
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IMPEDANCE DECREASED SHORTLY AFTER THE IMPLANT PROCEDURE; DURING IMPLANT IMPEDANCE WAS 461 OHMS, AFTER CLOSING THE POCKET IT WAS 200 OHMS, AND TWO HOURS LATER IT WAS 168 OHMS. IT WAS ALSO REPORTED THAT THE THRESHOLD HAD INCREASED. A CHEST X-RAY WAS TAKEN, AND IT DID NOT APPEAR THAT THE LEAD HAD MOVED. THE LEAD IS STILL IN USE. 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, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR Other (B)(4) IMPLANTABLE PULSE GENERATOR| 4965 IMPLANTABLE PACING LEAD