BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2203703 · Received August 11, 2011

    Report

    Report Number
    2649622-2011-12369
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    June 15, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S2
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, 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 AND ANALYZED AND THE HELIX/LOBE WAS DISTORTED/BENT. THERE WAS BLOOD IN/ON THE HELIX MECHANISM SLEEVE HEAD AND ON THE HELIX MECHANISM ITSELF, AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE RIGHT ATRIAL LEAD HELIX WOULD NOT DEPLOY. THE LEAD WAS NOT IMPLANTED, RATHER ANOTHER LEAD WAS USED. 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 74 YR Other 4194 IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB| 6947 IMPLANTABLE TACHY LEAD