BEUDAMED
    FDA Adverse Event Death Summary report: N

    PY2 PACING LEAD

    MDR report key: 1712815 · Received June 3, 2010

    Report

    Report Number
    1035166-2010-00030
    Event Type
    Death
    Date Received
    June 3, 2010
    Date of Event
    April 24, 2010
    Report Date
    June 3, 2010
    Manufacturer
    OSCOR INC.
    Product Code
    DTB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LEAD WAS CUT IN HALF AND ONLY THE PROXIMAL (CONNECTOR) END WAS RECEIVED (MEASURED 16.5 CM). THERE WAS DRIED BLOOD PRESENT ON THE CONNECTOR PIN AND THE INSULATION. THE VISUAL AND DIMENSIONAL (IS-1 CONNECTOR) INSPECTION WAS WITHIN SPECIFICATIONS. THE ELECTRICAL MEASUREMENTS COULD NOT BE PERFORMED ON PARTIAL DEVICE; THE CONTINUITY ON COIL AND CONNECTOR WAS PRESENT. NO CONCLUSION CAN BE DRAWN ON THIS PARTIAL DEVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THIS LEAD WAS RECEIVED ON (B) (6), 2010 FROM THEIR MEDICAL SALES REPRESENTATIVE. ACCORDING TO THE REPRESENTATIVE, THE PATIENT WAS IN THE HOSPITAL FOR PANCREATITIS ON (B) (6), 2010 WHEN HE SUPPOSEDLY WENT INTO AN EPISODE OF VT OR VF AND DIED THE NEXT DAY ((B) (6), 2010). THE PHYSICIAN ON STAFF STATED THAT THE ELA ICD DID NOT SHOCK THE PATIENT FOR VF AND CONSULTED BOTH THE PT'S CARDIOLOGIST AND FAMILY PHYSICIAN. THE WHOLE SYSTEM WAS EXPLANTED AND ANALYSIS HAS BEEN REQUESTED. THE LEAD WAS ACTIVELY IMPLANTED FOR APPROX 8 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PY2 PACING LEAD RETRACTABLE SCREW-IN PACING LEAD DTB OSCOR INC. PY2 44 RU 904955

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death