BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX NOVUS

    MDR report key: 2955433 · Received February 11, 2013

    Report

    Report Number
    2649622-2013-01377
    Event Type
    Injury
    Date Received
    February 11, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVALUATION SUMMARY: THE FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD ON THE DISTAL ELECTRODE, THE DISTAL CONNECTOR WAS DISTORTED AND BENT, AND THE LEAD APPEARED TO BE DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH THE HELIX FULLY RETRACTED AND THE IS-1 PIN BENT. VISUALLY THERE WAS NO HELIX DAMAGE. (B)(4).

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE THE SAME MODEL IS DISTRIBUTED. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. (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 DURING THE IMPLANT ATTEMPT THE HELIX OF THE LEAD WAS BROKEN. IT WAS ALSO REPORTED THAT THERE WAS POSSIBLY AN INFECTION. THE LEAD WAS NOT USED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    FURTHER INFORMATION REVEALED THERE WAS NO INFECTION RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58995 CAPSUREFIX NOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-52

    Patients

    Seq Age Sex Outcome Treatment
    1