BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUREFIX

    MDR report key: 2952288 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00522
    Event Type
    Injury
    Date Received
    February 9, 2013
    Date of Event
    November 21, 2012
    Report Date
    November 21, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    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

    PRODUCT EVENT SUMMARY: THE DISTAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED) AND THE OUTER INSULATION WAS HAD A BREACH/CUT. THE OUTER INSULATION HAD BLOOD INGRESSION. VISUAL ANALYSIS NOTED APPARENT EXPLANT DAMAGE. THE LEAD WAS RETURNED WITH THE OUTER INSULATION DAMAGED. A PARTIAL STYLET WAS STUCK IN LEAD AND THE KNOB WAS CUT OFF.

    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 ELECTIVE REPLACEMENT OF THE RIGHT VENTRICULAR (RV) LEAD, THE PHYSICIAN NOTICED THAT THERE WAS DAMAGE TO THE ATRIAL LEAD. THE ATRIAL LEAD WAS 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
    56262 SUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5072-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00081 YR Hospitalization| R 6931 IMPLANTABLE TACHY LEAD