BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG

    MDR report key: 1924731 · Received December 9, 2010

    Report

    Report Number
    1627487-2010-03488
    Event Type
    Injury
    Date Received
    December 9, 2010
    Date of Event
    October 25, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT TESTING WAS NOT PERFORMED AS THE CAUSE OF THE REPORTED COMPLAINT CANNOT BE DETERMINED THROUGH SUCH MEANS. EVALUATION METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY AND WAS APPROVED FOR USE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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 1 OF 3. REFERENCE MFR. REPORT #S 1627487-2010-03489 AND 1627487-2010-03490. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2010 CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION FOUND ON (B)(6) 2010 AT THE IPG POCKET AND BOTH LEAD INCISION SITES. A CULTURE WAS TAKEN; HOWEVER, THE RESULTS ARE UNK. THE PT IS REPORTEDLY RECOVERING WELL. SHE WILL BE IMPLANTED WITH ANOTHER SCS SYSTEM AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3788 3158106

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R