BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 1863150 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10568
    Event Type
    Malfunction
    Date Received
    October 9, 2010
    Date of Event
    July 23, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    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 BY THE PATIENT THAT "SOMETHING HAPPENED" TO ONE OF HIS LEADS. THE PATIENT ALSO REPORTED WEAKNESS OF LEGS AND FEELING "TIRED". IT WAS LATER REPORT BY THE CLINICIAN, THROUGH FOLLOW UP, THAT THE PATIENT WAS LAST SEEN (B)(6) 2010 AND THAT THE ATRIAL LEAD HAD "NOISE OF NO CLINICAL SIGNIFICANCE AND PATIENT WILL BE SEEN FOR GENERAL FOLLOW-UPS". THE LEAD REMAINS IMPLANTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSUREFIX IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5568 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other 4193 IMPLANTABLE PACING LEAD| 1488 COMPETITOR IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD| C154DWK IMPLANTABLE PACEMAKER/CARDIO/DEFIB