BEUDAMED
    FDA Adverse Event Death Summary report: N

    ISOLINE

    MDR report key: 1699860 · Received May 26, 2010

    Report

    Report Number
    2182863-2010-00048
    Event Type
    Death
    Date Received
    May 26, 2010
    Date of Event
    April 25, 2010
    Report Date
    April 29, 2010
    Manufacturer
    SORIN BIOMEDICA CRM S.R.L.
    Product Code
    MRM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE ANALYSIS ON THIS DEVICE IS PENDING. (B)(4)

    Additional Manufacturer Narrative · 1

    THE ANALYSIS ON THIS DEVICE IS PENDING.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE HOSPITAL FOR PANCREATITIS ON (B)(6) 2010. IT WAS REPORTED THAT THE PATIENT WENT INTO AN EPISODE OF VT OR VF AND DIED THE NEXT DAY. THE PHYSICIAN ON STAFF AT THE HOSPITAL REPORTED THAT THE ELA ICD THAT WAS ATTACHED TO THIS LEAD DID NOT SHOCK THE PATIENT. NOTE: THE ELA ICD WAS ALSO REPORTED ON AN MDR.

    Description of Event or Problem · 1

    PATIENT WAS ADMITTED TO THE HOSPITAL FOR PANCREATITIS ON (B) (6) 2010. IT WAS REPORTED THAT THE PATIENT WENT INTO AN EPISODE OF VT OR VF AND DIED THE NEXT DAY. THE PHYSICIAN ON STAFF AT THE HOSPITAL REPORTED THAT THE ELA ICD THAT WAS ATTACHED TO THIS LEAD DID NOT SHOCK THE PATIENT. NOTE: THE ELA ICD WAS ALSO REPORTED ON AN MDR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ISOLINE LEAD MRM SORIN BIOMEDICA CRM S.R.L. 2CR-6

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H