BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPY ABLATION CATHETER

    MDR report key: 1829422 · Received August 25, 2010

    Report

    Report Number
    2030404-2010-00104
    Event Type
    Malfunction
    Date Received
    August 25, 2010
    Date of Event
    July 6, 2010
    Report Date
    July 6, 2010
    Manufacturer
    IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY
    Product Code
    OAD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL EVENT DESCRIPTION ON (B)(6) 2010 AND RESPONSE TO F/U QUESTION ON (B)(6) 2010 DID NOT INDICATE A REPORTABLE EVENT. FURTHER INFO PROVIDED ON (B)(6) 2010, INDICATED THAT THE EVENT IS REPORTABLE. THE DEVICE WAS NOT RETURNED FOR EVAL. THE DEVICE HISTORY RECORD FOR LOT K23792 WAS REVIEWED TO ENSURE THAT EACH MFR AND INSPECTION OPERATION WAS FOLLOWED BY THE APPROPRIATE SIGNATURE AND DATE, INDICATING THE PROCESS WAS PERFORMED IN ACCORDANCE WITH SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS LEAK AT THE TIP DURING ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPY ABLATION CATHETER CARDIAC PERCUTANEOUS ABLATION CATHETER OAD IRVINE BIOMEDICAL, A ST. JUDE MEDICAL COMPANY 83502 K23792

    Patients

    Seq Age Sex Outcome Treatment
    1