BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2091629 · Received April 28, 2011

    Report

    Report Number
    1627487-2011-01442
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    March 18, 2011
    Report Date
    March 31, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2011-01443. THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG AND SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT ON (B)(6) 2011, THE PATIENT COMPLAINED OF SEVERE LEAD INCISION SITE PAIN, WEAKNESS IN HER LEGS AND FEELING OVERSTIMULATION. SHE WAS ALLEGEDLY ADMITTED TO THE HOSPITAL FOR INFECTION AT THE LEAD INCISION SITE. CONSEQUENTLY, THE PHYSICIAN EXPLANTED HER SYSTEM ON (B)(6) 2011. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE INFECTION AND THE PATIENT'S CONDITION WERE UNSUCCESSFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3269084

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R