BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2981578 · Received February 27, 2013

    Report

    Report Number
    2649622-2013-02483
    Event Type
    Injury
    Date Received
    February 27, 2013
    Report Date
    April 9, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 PRODUCT: 0180 COMPETITOR DEFIBRILLATION LEAD (B)(6) 2010. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: DUE TO EXPLANT DAMAGE IT IS UNKNOWN IF THE ENTIRE LEAD WAS RETURNED AND ANALYZED. ANALYSIS RESULTS WERE AN INSULATION BREACH DUE TO RIB/CLAVICLE CRUSH. VISUAL SUMMARY OF THE LEAD NOTED THE LEAD WAS STRETCHED. THE LEAD INSULATION WAS DISTORTED AND THE INNER INSULATION WAS FOUND TO BE KINKED AND BUCKLED. THE LEAD CONDUCTOR WAS DISTORTED WITH OVER ROTATION, PULLED, STRETCHED AND OVERSTRESSED. THE OUTER INSULATION WAS DEPRESSED AND CUT. THE LEAD HELIX WAS PULLED, STRETCHED, OVERSTRESSED AND BENT. THE LEAD WAS FOUND WITH A WHITE SUBSTANCE ON THE OUTER INSULATION WITH STRESS CRACKING. BLOOD WAS ALSO NOTED ON THE ELECTRODE, THE PROXIMAL CONDUCTOR, AND DISTAL CONDUCTOR. THE ANALYST NOTED THAT THE LEAD WAS RETURNED WITH SEVERE EXPLANT DAMAGE.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERE WAS A WARNING DUE TO HIGH IMPEDANCE ON THE ATRIAL LEAD. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE THERE WAS A WARNING DUE TO HIGH IMPEDANCE ON THE ATRIAL LEAD. THE ATRIAL LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83867 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4) IMPLANTABLE CARDIOVERTER DEFIBRILLATOR