BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2051032 · Received April 12, 2011

    Report

    Report Number
    2649622-2011-05472
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    January 26, 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
    LA, 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 DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES, RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE CONNECTOR. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE DISTAL CONDUCTOR WAS DISTORTED. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED. WHEN THE HELIX WAS RETRACTED DURING THE PROCEDURE, THE IS-1 CONNECTOR PIN WAS TURNED AN EXCESSIVE NUMBER OF TIMES, RESULTING IN DISTORTION OF THE DISTAL CONDUCTOR WITHIN THE CONNECTOR. IT WAS ALSO NOTED THAT THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT, THE ATRIAL LEAD SHOWED HIGH IMPEDANCE AND WAS REPOSITIONED SEVERAL TIMES. THE HELIX WOULD NOT DEPLOY AND THE HELIX FIXATION MECHANISM FROZE. THE LEAD WAS NOT IMPLANTED AND AN ATTEMPT WAS MADE TO PLACE A NEW LEAD, BUT THE SECOND LEAD ALSO HAD THE SAME ISSUES. A THIRD LEAD WAS IMPLANTED SUCCESSFULLY. 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 85 YR Other