BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2964527 · Received February 15, 2013

    Report

    Report Number
    2649622-2013-02118
    Event Type
    Injury
    Date Received
    February 15, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: THE FULL LEAD WAS RETURNED AND ANALYSIS FOUND NO ANOMALIES. HOWEVER, THE OUTER INSULATION WAS CUT. THE DISTAL ELECTRODE WAS COVERED IN BLOOD. THERE WAS BLOOD ON THE PROXIMAL CONDUCTOR (NOT OBSTRUCTED). VISUAL ANALYSIS NOTED THAT THE LEAD WAS RETURNED WITH BLOOD IN THE SLEEVE HEAD, AND A CUT ON THE OUTER INSULATION. THE CUT ON THE OUTER INSULATION IS LIKELY DUE TO EXPLANT DAMAGE. HELIX EXTENSION/RETRACTION AND LENGTH TESTING WERE PERFORMED AND ALL RESULTS, INCLUDING ELECTRICAL TESTING, WERE WITHIN SPECIFIED PARAMETERS. (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 LEAD WAS MALFUNCTIONING. THE 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 FURTHER REPORTED THAT THE LEAD MALFUCNTION WAS HIGH THRESHOLDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67957 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Hospitalization| R (B)(4) IMPLANTABLE PULSE GENERATOR (IPG)