BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELLENCE SS+

    MDR report key: 2812069 · Received October 31, 2012

    Report

    Report Number
    2649622-2012-15677
    Event Type
    Malfunction
    Date Received
    October 31, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO, INC.
    Product Code
    DTB
    PMA / PMN Number
    P850089/S40
    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 FULL LEAD WAS RETURNED IN SEGMENTS, WAS ANALYZED AND ANALYSIS NOTED THE OUTER INSULATION HAD A BREACHED DEPRESSION. IT WAS NOTED THAT ALL CONDUCTORS WERE DISTORTED, ALL CONDUCTORS WERE CUT, THERE WAS BLOOD/BODY FLUID ON ALL CONDUCTORS (NOT OBSTRUCTED), THE OUTER INSULATION WAS KINKED/BUCKLED, ALL INSULATORS WERE BREACHED CUT, THE OUTER INSULATION WAS BREACHED CUT, HAD A WHITE SUBSTANCE AND COSMETIC DEPRESSION.

    Description of Event or Problem · 1

    THE LEAD WAS RETURNED TO THE MANUFACTURER AFTER BEING EXPLANTED DUE TO AN UNRELATED INFECTION, WAS 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 EXCELLENCE SS+ IMPLANTABLE PACING LEAD DTB MEDTRONIC PUERTO RICO, INC. IML49JB

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other VEDR01 IMPLANTABLE PULSE GENERATOR| IML49B IMPLANTABLE PACING LEAD