BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2951447 · Received February 9, 2013

    Report

    Report Number
    2649622-2013-00102
    Event Type
    Injury
    Date Received
    February 9, 2013
    Report Date
    November 15, 2012
    Manufacturer
    MPRI
    Product Code
    DTB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    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. EVALUATION SUMMARY (B)(4): THE LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. THE INSULATION WAS DISTORTED AND INNER TUBING KINKED/BUCKLED. THE LEAD WAS STRETCHED AND DISTAL END/ELECTRODES WAS COVERED IN BLOOD AND HAD BODY TISSUE/FIBROTIC GROWTH. THE HELIX WAS DISTORTED BENT. THE OUTER INSULATION HAD COSMETIC DEPRESSION. THE LEAD CONDUCTOR PROXIMAL HAD BLOOD NOT OBSTRUCTED. THE LEAD INSULATION WAS BREACHED WITH INSULATION DEPRESSION AND INSULATION CUT; THE INNER INSULATION WERE DISTORTED AND KINKED/BUCKLED. CONCOMITANT PRODUCT: 6947 IMPLANTABLE TACHY LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIUM (RA) LEAD WAS REMOVED DUE TO MEDICAL JUDGEMENT. THE RA LEAD WAS RETURNED, 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
    55890 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| L| R (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB