BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 3153284 · Received June 8, 2013

    Report

    Report Number
    2649622-2013-05921
    Event Type
    Injury
    Date Received
    June 8, 2013
    Report Date
    March 5, 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

    PRODUCT EVENT SUMMARY: THE LEAD WAS RETURNED, ANALYZED AND ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR OF THE LEAD AND IT WAS NOT OBSTRUCTED. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BLOOD. THE DISTAL LV (LOW VOLTAGE) ELECTRODE OF THE LEAD WAS COVERED IN BODY TISSUE/FIBROTIC GROWTH. THE OUTER INSULATION OF THE LEAD WAS EXTRINSICALLY BREACHED DUE TO A CUT. VISUAL SUMMARY ANALYSIS OF THE LEAD INDICATED APPARENT EXPLANT DAMAGE.

    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: 5076 IMPLANTABLE PACING LEAD (B)(6) 2012. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE RIGHT VENTRICULAR (RV) LEAD HAD NO CAPTURE AT MAX OUTPUT DUE TO POSSIBLE MICRO DISLODGEMENT. THEREFORE, THE RV LEAD WAS REMOVED AND REPLACED WITH A NEW LEAD. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    256101 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Hospitalization| R (B)(4) IMPLANTABLE PACEMAKER