BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE

    MDR report key: 2123225 · Received June 14, 2011

    Report

    Report Number
    2649622-2011-07933
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    February 7, 2011
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S9
    Removal / Correction Number
    ASKU
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FS
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND THE LEAD WAS RETURNED WITH THE GUIDE TOOTH DAMAGED. IT WAS ALSO NOTED THAT THE OUTER INSULATION HAD A COSMETIC CUT AND THE LEAD WAS DAMAGED AT IMPLANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE IMPLANT THERE WAS HIGH UNSTABLE AND UNMEASURABLE THRESHOLD AND HIGH RESISTANCE/IMPEDANCE. THE LEAD WAS NOT IMPLANTED. A DIFFERENT LEAD WAS USED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRYSTALLINE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. ICF09B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other