BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2133578 · Received June 16, 2011

    Report

    Report Number
    1627487-2011-00833
    Event Type
    Injury
    Date Received
    June 16, 2011
    Date of Event
    May 19, 2011
    Report Date
    May 19, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER WAS INCLUDED IN A FIELD ADVISORY. SJM HAS LIMITED INFO 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 3 OF 3. REFERENCE MFR REPORT #S: 1627487-2011-00831 AND 1627487-2011-00832. THE PT RECEIVED AN SCS SYSTEM INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS FROM DIFFERENT LOTS. IT WAS REPORTED THAT PT WAS FEELING STIMULATION IN HIS RIBS. EFFORTS TO RECAPTURE EFFECTIVE THERAPY COVERAGE VIA REPROGRAMMING WAS UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEADS. AT THAT TIME, THE IPG WAS ALSO REPLACED AS THE DEVICE HAD NOT BEEN CHARGED IN MONTHS AND NO COMMUNICATION COULD BE ESTABLISHED WITH IT USING EITHER THE PROGRAMMER OR CHARGING SYSTEM. EFFECTIVE STIMULATION WAS CAPTURED FOR THE PT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2834055

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANTED:| SCS LEAD EXTENSION: MODEL 1194