BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPSUREFIX

    MDR report key: 3993754 · Received August 8, 2014

    Report

    Report Number
    2649622-2014-09138
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 18, 2014
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS AND ANALYZED. THE INNER INSULATION OF THE LEAD DEVELOPED A BREACH DUE TO MIO (METAL ION OXIDATION) WHILE IN VIVO. VISUAL ANALYSIS FOUND INNER INSULATION BREACHED IN-VIVO/ METAL ION OXIDATION. THE BREACHED INSULATION DID CONTRIBUTE TO THE ELECTRICAL COMPLAINTS.

    Additional Manufacturer Narrative · 1

    THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: ICD, IMPLANTED: (B)(6) 2003; 419378 LEAD, IMPLANTED: (B)(6) 2003. (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL (RA) LEAD EXHIBITED HIGH THRESHOLDS AND LOW IMPEDANCES. IT WAS FURTHER REPORTED THAT THE RA LEAD EXHIBITED UNDERSENSING/FAILURE TO SENSE, WITH P WAVES OF 0.1 MV. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT. THE PATIENT IS PART OF THE SLS CLINICAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467385 CAPSUREFIX ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 4568-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R 694758 LEAD