BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2864896 · Received December 10, 2012

    Report

    Report Number
    2649622-2012-17568
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    January 3, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, 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. ADD'L DEVICE: 6949 IMPLANTABLE TACHY LEAD (B)(6) 2006. (B)(4).

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED IN SEGMENTS, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THE OUTER INSULATION HAD A COSMETIC CUT AND THE VISUAL SUMMARY NOTED APPARENT EXPLANT DAMAGE. THE DISTAL END OF THE LEAD AND ELECTRODE WERE COVERED IN BODY TISSUE AND FIBROTIC TISSUE. THE OUTER INSULATION WAS NOTED TO HAVE A COSMETIC DEPRESSION AND A BREACH OR CUT IN THE INSULATION. BLOOD (NOT OBSTRUCTED) WAS NOTED ON THE PROXIMAL LEAD CONDUCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT ATRIAL LEAD DISLODGED SHORTLY AFTER THE IMPLANT PROCEDURE. THE LEAD WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR Hospitalization| R (B)(4) IMPLANTABLE CARDIODEFIBRILATOR