BEUDAMED
    FDA Adverse Event Death Summary report: N

    CAPSUREFIXNOVUS

    MDR report key: 2895592 · Received January 3, 2013

    Report

    Report Number
    2649622-2013-00009
    Event Type
    Death
    Date Received
    January 3, 2013
    Date of Event
    December 12, 2012
    Report Date
    March 7, 2013
    Manufacturer
    MPRI
    Product Code
    DTB
    PMA / PMN Number
    P930039/S009
    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. (B)(4). CONCOMITANT MEDICAL PRODUCTS: ADDR01 IMPLANTABLE PULSE GENERATOR, (B)(6) 2009. ADDITIONAL INFORMATION OBTAINED FROM THE DEVICE DIAGNOSTICS, SAVED ON A DISK AND SENT TO TECHNICAL SERVICES INDICATES THE PATIENT HAD "SOME PRETTY FAST" VENTRICULAR CYCLES; NO LEAD WARNINGS WERE OBSERVED.

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY # (B)(4) -THE FULL LEAD WAS RETURNED TO THE MANUFACTURER AND ANALYZED. NO ANOMALIES WERE FOUND. THE LEAD WAS STRETCHED, AND THERE WAS APPARENT EXPLANT DAMAGE. THE PROXIMAL AND DISTAL CONDUCTORS WERE PULLED/STRETCHED, AND THERE WAS BLOOD ON THE DISTAL ELECTRODE. A VISUAL ANALYSIS WAS PERFORMED ONLY. FURTHER REVIEW PROMPTED A CHANGE IN THE DEVICE ANALYSIS RESULTS. THE CHANGE IS REFLECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 1

    A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS DECEASED. THE MANUFACTURER'S FIELD REPRESENTATIVE CALLED INTO TECHNICAL SERVICES TO FIND OUT IF THE DIAGNOSTIC DATA ON THE IMPLANTABLE PULSE GENERATOR (IPG) COULD HELP DETERMINE TIME OF DEATH. THE REPRESENTATIVE FURTHER INDICATED THAT THE PATIENT'S BODY WAS FOUND IN THE WOODS THE PREVIOUS DAY AND THE DEVICE SYSTEM WAS EXPLANTED THE NEXT DAY. THE CAUSE OF DEATH WAS REQUESTED AND NOT RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2872 CAPSUREFIXNOVUS ELECTRODE, PACEMAKER, PERMANENT DTB MPRI 5076-45

    Patients

    Seq Age Sex Outcome Treatment
    1 00058 YR Death 5076-58 IMPLANTABLE PACING LEAD