BEUDAMED
    FDA Adverse Event Death Summary report: N

    ELECTRODE, PACEMAKER, PERMANENT

    MDR report key: 2970066 · Received February 20, 2013

    Report

    Report Number
    2649622-2013-02459
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    December 13, 2012
    Report Date
    March 28, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039
    Adverse Event
    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. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED. FOLLOW-UP IS IN PROGRESS. THE DECISION TO REPORT WAS DETERMINED BASED ON INFORMATION THAT WAS AVAILABLE AT THE TIME OF DECISION. SHOULD ADDITIONAL INFORMATION BECOME KNOWN THROUGH FOLLOW-UP, IT WILL BE ADDED TO THE EVENT AND PROCESSED ACCORDINGLY. CONTINUED: (B)(4) CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (B)(6) 2011. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. ONE OF THE PACING LEADS IS A COMPETITIVE PRODUCT. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST THE IMPLANT OF THE DEVICE SYSTEM.

    Description of Event or Problem · 1

    A CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER SYSTEM WAS RETURNED TO THE MANUFACTURER FROM AN UNKNOWN SOURCE WITH NO INFORMATION. ONE OF THE PACING LEADS IS A COMPETITIVE PRODUCT. FURTHER REVIEW OF THE MANUFACTURER'S DATABASE INDICATED THE PATIENT DIED APPROXIMATELY ONE MONTH POST THE IMPLANT OF THE DEVICE SYSTEM. A CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    73845 ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-58

    Patients

    Seq Age Sex Outcome Treatment
    1 00090 YR Death (B)(4) IMPLANTABLE PACING LEAD