BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNK

    MDR report key: 1679021 · Received May 10, 2010

    Report

    Report Number
    1721279-2010-00017
    Event Type
    Death
    Date Received
    May 10, 2010
    Date of Event
    April 15, 2010
    Report Date
    May 10, 2010
    Manufacturer
    SPECTRANETICS CORP.
    Product Code
    MFA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MFR DATES FOR ALL DEVICES: UNK.

    Description of Event or Problem · 1

    INDICATION FOR PROCEDURE: UNK. PROCEDURE: DURING A (B) (6) 2010 CASE, AN EP LAB EMPLOYEE REPORTED TO THE SPNC REPRESENTATIVE THAT "AN ELDERLY WOMAN WAS TAKEN INTO THE OR AFTER A LEAD REMOVAL CASE A FEW DAYS AGO AND DIDN'T MAKE IT." SEVERAL ATTEMPTS WERE MADE TO OBTAIN INFO ABOUT THE CASE, BUT WERE UNSUCCESSFUL. ANALYSIS: THERE WERE NO DEVICES RETURNED FOR ANALYSIS. NO PRODUCT-RELATED COMPLAINTS ASSOCIATED WITH THIS EVENT WERE REPORTED BY THE PHYSICIAN. PT OUTCOME: DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK UNK MFA SPECTRANETICS CORP. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Death GENERATOR 4 EXCIMER LASER