BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2811012 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15823
    Event Type
    Injury
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH), WAS KINKED/BUCKLED, AND EXHIBITED A COSMETIC AND BREACHED CUT. THE OUTER INSULATION ALSO EXHIBITED A COSMETIC DEPRESSION, AND THE INNER INSULATION AND TUBING WERE KINKED/BUCKLED. THE PROXIMAL CONDUCTOR WAS DISTORTED AND STRETCHED, AND BLOOD/BODY FLUID WAS FOUND ON ALL CONDUCTORS (NOT OBSTRUCTED). THE REMOVAL WIRE WAS FOUND STUCK IN THE DISTAL CONDUCTOR. BLOOD WAS FOUND IN/ON THE HELIX/LOBE MECHANISM, AND THE LEAD APPEARED TO HAVE BEEN STRETCHED. (B)(4) OUTER INSULATION BREACHED (CLAVICLE-RIB CRUSH). (B)(4) DISTAL SEGMENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD WAS EXPLANTED AND REPLACED DUE TO MEDICAL JUDGEMENT. THE LEAD WAS RETURNED TO THE MANUFACTURER, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| O| R (B)(4) IMPLANTABLE PULSE GENERATOR| 5076 IMPLANTABLE PACING LEAD