BEUDAMED
    FDA Adverse Event Death Summary report: N

    CRYSTALLINE

    MDR report key: 1822014 · Received September 1, 2010

    Report

    Report Number
    2649622-2010-08953
    Event Type
    Death
    Date Received
    September 1, 2010
    Date of Event
    June 30, 2007
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P930039/S9
    Removal / Correction Number
    ASKU
    Report Source
    Manufacturer report
    Reporter Location
    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) OUTER INSULATION BREACHED DEPRESSION, ALL CONDUCTORS BLOOD/BODY FLUID (NOT OBSTRUCTED). PROXIMAL SEGMENT RETURNED AND ANALYZED.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER FOLLOWING THE PATIENT'S DEATH, ANALYZED, AND SUBSEQUENTLY TESTED OUT OF SPECIFICATION. THERE IS NO ALLEGATION FROM HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.

    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 73 YR Death (B)(4) IMPLANTABLE PACING LEAD| 860 IMPLANTABLE PULSE GENERATOR