BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2190768 · Received July 26, 2011

    Report

    Report Number
    1627487-2011-03354
    Event Type
    Injury
    Date Received
    July 26, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2011-03353. REFERENCE MFR REPORT: 1627487-2011-03369. THE PT REC'D A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT ONE OF THE PT'S LEADS MIGRATED. THE PT ELECTED TO HAVE PADDLE LEAD IMPLANTED. DURING THE LEAD REMOVAL, ONE OF THE LEADS BROKE OFF INSIDE THE IPG HEADER AND IPG WAS REPLACED AS WELL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3244584

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS ANCHOR: MODEL 1192 (2)| IMPLANTED: