BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 1963699 · Received December 21, 2010

    Report

    Report Number
    1627487-2010-03874
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    November 23, 2010
    Report Date
    November 23, 2010
    Manufacturer
    ST JUDE MEDICAL- NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 1 OF 2. REFERENCE MFR REPORT #1627487-2010-03890. THE IPG AND EXTENSION WERE INTENDED FOR PT IMPLANT ((B)(6)). IMPEDANCE TESTING CONDUCTED PRIOR TO THE PROCEDURE REVEALED HIGH READINGS FOR SEVERAL LEAD CONTACTS WHEN TESTED IN CONJUNCTION WITH THE IPG. WHEN TAKEN INDEPENDENTLY, THE IMPEDANCE READINGS FOR THE LEAD CONTACTS WERE WITHIN SPECIFICATIONS. A DIFFERENT IPG AND EXTENSION WERE USED TO COMPLETE THE PROCEDURE. THE AFFECTED DEVICES WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE LOT NUMBER AND MANUFACTURING DATE AND EXPIRATION DATE OF THE IPG ARE UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL- NEUROMODULATION DIVISION 3788

    Patients

    Seq Age Sex Outcome Treatment
    1