BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE

    MDR report key: 1920805 · Received December 13, 2010

    Report

    Report Number
    2649622-2010-12340
    Event Type
    Malfunction
    Date Received
    December 13, 2010
    Date of Event
    August 15, 2010
    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
    SP
    Reporter Occupation
    PHYSICIAN

    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 NO ANOMALIES WERE FOUND. THE INNER INSULATION WAS KINKED AND BUCKLED. THERE WAS BLOOD IN/ON HELIX MECHANISM. THE LEAD WAS STRETCHED AND NOTED TO BE DAMAGED AT IMPLANT. THE ANALYST NOTED THAT THERE ARE NO SETSCREW MARKS ON THE IS-1 PIN. THE LEAD WAS NOT FULLY INSERTED INTO THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE LEAD WAS CONNECTED TO THE PACEMAKER THE IMPEDANCE WAS TOO HIGH AS THOUGH "THE DEVICE DIDN'T RECOGNIZE THE LEAD". THE 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
    1 CRYSTALLINE IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. ICF09B ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 Other