BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1855039 · Received October 5, 2010

    Report

    Report Number
    2649622-2010-09262
    Event Type
    Malfunction
    Date Received
    October 5, 2010
    Date of Event
    August 11, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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) NO ANOMALIES FOUND; FULL LEAD WAS RETURNED AND ANALYZED. BLOOD IN/ON HELIX/LOBE MECHANISM. CORRECTION: PATIENT OUTCOME CHANGED TO OTHER. DEATH CHANGED TO NOT APPLICABLE.

    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. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT IT WAS NOT POSSIBLE TO MOVE THE LEAD. AFTER VISUAL INSPECTION, THE HELIX WAS 2MM OUT OF THE LEAD. THE PHYSICIAN TRIED TO RETRACT THE HELIX AND NEEDED A HIGH NUMBER OF ROTATIONS. THE PHYSICIAN TRIED TO EXTRACT THE HELIX AND HE NEEDED MORE THAN 15 ROTATIONS. THE HELIX JUMPED OUT AND HE DECIDED TO USE ANOTHER LEAD. 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 NOVUS ASKU DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R