BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX

    MDR report key: 2053345 · Received April 13, 2011

    Report

    Report Number
    2649622-2011-05876
    Event Type
    Malfunction
    Date Received
    April 13, 2011
    Date of Event
    February 3, 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
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4): THE FULL LEAD WAS RETURNED, ANALYZED AND THERE WAS A NON-ELECTRICAL MISCELLANEOUS FINDING ON THE TIP ELECTRODE. IT WAS NOTED THAT THE LEAD WAS RECEIVED WITH THE HELIX FULLY RETRACTED. THE HELIX HAD BEEN OVER-RETRACTED, WHICH MOST LIKELY CONTRIBUTED TO THE HELIX ISSUE. IT WAS ALSO NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM, THERE WAS A TIP SEAL OBSERVATION AND THE LEAD APPEARED DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT IMPLANT ATTEMPT OF THE ATRIAL LEAD, THE FIRST PLACEMENT DID NOT YIELD AN ACCEPTABLE THRESHOLD. UPON REPOSITIONING, THE LEAD HELIX WOULD NOT EXTEND, EVEN WITH REPEATED ATTEMPTS. THE LEAD WAS REMOVED AND REPLACED AND 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 Other