BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 1862959 · Received October 9, 2010

    Report

    Report Number
    2649622-2010-10612
    Event Type
    Injury
    Date Received
    October 9, 2010
    Date of Event
    July 29, 2010
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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 HELIX CAN NOT BE EXTENDED AND RETRACTED DUE TO THE DISTAL CONDUCTOR BEING DISTORTED AND FRACTURED WITHIN THE CONNECTOR. THE DISTAL CONDUCTOR WAS OVER-RETRACTED. THE HELIX WAS FOUND DISTORTED/BENT AND BLOOD PRESENT IN/ON THE HELIX MECHANISM. FULL LEAD WAS RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS IMPLANTED AND THEN DISLODGED LATER ON THE SAME DAY AS IMPLANT. THE LEAD WAS ATTEMPTED TO BE READJUSTED THE NEXT DAY. INITIALLY THE SCREW PERFORMED NORMALLY, BUT AFTER A FEW ATTEMPTS THE SCREW COULD NOT EXTEND AND RETRACT. THE LEAD WAS EXPLANTED AND A NEW LEAD WAS 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 NOVUS IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. 5076 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention