BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2130588 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-01648
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    March 26, 2010
    Report Date
    July 1, 2010
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    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

    THE PATIENT (B)(6) RECEIVED HIS SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THAT THE PHYSICIAN EXPLANTED AND REPLACED THE PATIENT'S IPG WITH TWO IPGS OF A SMALLER MODEL ON (B)(6) 2010. THE PHYSICIAN ALSO ALLEGEDLY ADDED A SURGICAL LEAD DURING THE SAME PROCEDURE. THE REASON FOR THE EXPLANT IS CURRENTLY UNKNOWN. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 113956

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANTED:| SCS EXTENSION: MODEL 3383 (X2)| SCS LEAD: MODEL 3186 (X2)| IMPLANTED: