BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE

    MDR report key: 3153551 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-06085
    Event Type
    Malfunction
    Date Received
    June 8, 2013
    Date of Event
    March 25, 2013
    Report Date
    March 25, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US WHERE A SIMILAR 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 FULL LEAD WAS RETURNED, ANALYZED, AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: NO EVAL EXPLAIN CODE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN IMPLANT ATTEMPT, THE PHYSICIAN WAS UNABLE TO INSERT THE STYLET UP TO THE TIP OF THE LEAD. THE PHYSICIAN TRIED SEVERAL TIMES BUT THE STYLET COULD NOT REACH UP TO THE TIP OF THE LEAD AND THEREFORE THE PHYSICIAN COULD NOT POSITION THE LEAD IN THE ATRIUM. THE LEAD WAS NOT IMPLANTED AND A PASSIVE FIXATION 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
    258361 CRYSTALLINE ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00080 YR