BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2952581 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00621
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 19, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT SUMMARY: THE DISTAL PORTION OF THE LEAD WAS RETURNED, ANALYZED, AND ANALYSIS REVEALED THAT THE PROXIMAL CONDUCTOR WAS FRACTURED AT THE 1ST RIB/CLAVICLE LOCATION. IT WAS NOTED THAT THE DISTAL CONDUCTOR WAS KINKED/BUCKLED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR, THE PROXIMAL CONDUCTOR WAS DISTORTED AT THE 1ST RIB/CLAVICLE LOCATION, THE PROXIMAL CONDUCTOR WAS DISTORTED FROM PULLED/STRETCHED/OVERSTRESSED, THE PROXIMAL CONDUCTOR WAS FRACTURED FROM PULLED/STRETCHED/OVERSTRESSED, THE DISTAL CONDUCTOR WAS DISTORTED FROM PULLED/STRETCHED/OVERSTRESSED, THERE WAS BLOOD ON THE DISTAL CONDUCTOR, THE INNER INSULATION WAS TORN, THE OUTER INSULATION WAS TORN, CUT, HAD A COSMETIC DEPRESSION, AND HAD A WHITE SUBSTANCE, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR, THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. IT WAS ALSO NOTED IN THE ANALYSIS COMMENTS THAT THE LEAD WAS RETURNED WITH SEVERE EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT PRODUCT: 507645 IMPLANTABLE PACING LEAD: (B)(6) 2001. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR LEAD WAS SUSPECT OF LEAD FRACTURE AS THE IMPEDANCE MEASUREMENT WAS OF UNDEFINED RESISTANCE. IT WAS ALSO REPORTED THAT THE ATRIAL LEAD WAS ALSO SUSPECT OF A PERFORMANCE ISSUE AS THE ATRIAL LEAD RECENTLY HAD A SIGNIFICANT INCREASE IN CAPTURE THRESHOLD. THE RIGHT VENTRICULAR AND ATRIAL LEADS WERE EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56873 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1 00048 YR Hospitalization| R ADDR01 IMPLANTABLE PULSE GENERATOR