BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSURE EPI

    MDR report key: 2083002 · Received May 10, 2011

    Report

    Report Number
    2182208-2011-00677
    Event Type
    Injury
    Date Received
    May 10, 2011
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    PMA / PMN Number
    P950024
    Removal / Correction Number
    ASKU
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD HAS NOW BEEN RETURNED. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED AND THE PRIMARY FINDING WAS THE DISTAL CONDUCTOR WAS FRACTURED. IT WAS ALSO NOTED THAT THE DISTAL CONDUCTOR WAS DISTORTED AND THERE WAS BLOOD/BODY FLUID (NOT OBSTRUCTED). IT WAS ALSO NOTED THE OUTER INSULATION WAS BREACHED CUT AND THERE WAS A WHITE SUBSTANCE. THE LEAD WAS FLEXED. THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE LEAD FRACTURED, HAD AN IMPEDANCE MEASUREMENT GREATER THAN 2000 OHMS, AND THERE WAS LOSS OF CAPTURE. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    ASKU

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPSURE EPI IMPLANTABLE PACING LEAD DTB MEDTRONIC, INC. 4965 ASKU

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Hospitalization| R COMPETITOR IMPLANTABLE PULSE GENERATOR| COMPETITOR IMPLANTABLE PULSE GENERATOR| COMPETITOR IMPLANTABLE PULSE GENERATOR