BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 2973654 · Received February 19, 2013

    Report

    Report Number
    1627487-2013-05225
    Event Type
    Injury
    Date Received
    February 19, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    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 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 2 OF 2. REFERENCE MFR REPORT#: 1627487-2013-05224. THE PT HAD AN SCS SYSTEM (INCLUDING TWO LEADS FROM THE SAME LOT) FOR OFF-LABEL USE. IT WAS REPORTED THE PT'S LEAD(S) AND THE IPG SITE DID NOT HEAL PROPERLY FOLLOWING BEING IMPLANTED. THE DOCTOR BELIEVES THE PT DID NOT HEAL PROPERLY DUE TO DIABETES. AS A RESULT, THE PT'S SCS SYSTEM WAS EXPLANTED. THE EXPLANTED PRODUCT WILL NOT BE RETURNED TO SJM. CULTURES WERE TAKEN POST-OP, BUT THE RESULTS ARE UNK AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72586 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3763718

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)| EXPLANT: