BEUDAMED
    FDA Adverse Event Death Summary report: N

    SYNCRA CRT-P

    MDR report key: 2970068 · Received February 20, 2013

    Report

    Report Number
    9614453-2013-00507
    Event Type
    Death
    Date Received
    February 20, 2013
    Date of Event
    December 13, 2012
    Report Date
    May 1, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    NVZ
    PMA / PMN Number
    P010015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: (B)(4) THE DEVICE WAS RETURNED AND ANALYZED. ANALYSIS WAS PERFORMED AND NO ANOMALIES WERE FOUND.

    Additional Manufacturer Narrative · 1

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

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

    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.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72898 SYNCRA CRT-P PULSE GENERATOR, PERMANENT, IMPLANTABLE NVZ IPG MFG SWITZERLAND C2TR01

    Patients

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