BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IEON MINI

    MDR report key: 2771988 · Received October 2, 2012

    Report

    Report Number
    1627487-2012-12192
    Event Type
    Injury
    Date Received
    October 2, 2012
    Date of Event
    September 10, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    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 FIELD ADVISORIES AND A FIELD ACTION; 1627487-07262012-002-R, 1627487-07262012-001-C. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT STOPPED USING THE SYSTEM FOR AT LEAST SIX MONTHS AND THE IPG BATTERY APPEARS DEPLETED. THE PATIENT REALIZED THE BENEFIT OF THE THERAPY AND WOULD LIKE THE SYSTEM REPLACED. ON (B)(6) 2012 THE IPG WAS REPLACED, THE SYSTEM WAS TESTED INTRA-OPERATIVELY AND EVERYTHING WAS FUNCTIONING PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IEON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2770069

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Required Intervention SCS LEAD: MODEL 3288| IMPLANT: