BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE ACTIVE FIXATION

    MDR report key: 3863382 · Received June 10, 2014

    Report

    Report Number
    2649622-2014-06640
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 2, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 FULL LEAD WAS RETURNED AND ANALYZED. ELECTRICAL RESISTANCE AND CROSS CONTINUITY TEST RESULTS WERE WITHIN SPECIFICATION. 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 IMPLANTABLE PACING LEAD DISPLAYED HIGH PACING THRESHOLDS. THE LEAD WAS REPLACED AND NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339084 CRYSTALLINE ACTIVE FIXATION ELECTRODE, PACEMAKER, PERMANENT DTB MPRI ICQ09B58

    Patients

    Seq Age Sex Outcome Treatment
    1 00073 YR