BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRYSTALLINE

    MDR report key: 2812679 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-16943
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S017
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE MEDIAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS NOTED THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE INNER TUBING WAS KINKED/BUCKLED, AND THE OUTER INSULATION HAD COSMETIC ENVIRONMENTAL STRESS CRACKING. (B)(4): THE DISTAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS NOTED THE PROXIMAL CONDUCTOR WAS FRACTURED. IT WAS NOTED THE PROXIMAL CONDUCTOR WAS DISTORTED, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), AND THE OUTER INSULATION WAS BREACHED (CLAVICLE-RIB CRUSH), THE OUTER INSULATION WAS MELTED, HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, WAS BREACHED CUT AND HAD A WHITE SUBSTANCE. THERE WAS BLOOD IN/ON THE HELIX/LOBE MECHANISM.

    Description of Event or Problem · 1

    THE LEADS WERE RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO AN UNRELATED INFECTION. THE LEADS WERE ANALYZED AND TESTED OUT OF SPECIFICATION. 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. ICQ09B

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other SEDR01 IMPLANTABLE PULSE GENERATOR