BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44C SURGICAL LEAD

    MDR report key: 1991099 · Received February 11, 2011

    Report

    Report Number
    1627487-2011-02185
    Event Type
    Injury
    Date Received
    February 11, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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: 1627487-2011-02184. THE PT RECEIVED AN SCS SYSTEM, INCLUDING AN IPG AND A SURGICAL LEAD, ON (B)(6) 2010. IT WAS REPORTED THE PT HAS A RASH AT THE IPG IMPLANT SITE. ACCORDING TO THE PT, THE ORIGINAL ONSET WAS APPROXIMATELY ONE WEEK POST-OPERATIVE. THE PT HAS REPORTEDLY BEEN ON ANTIBIOTICS FOR THE LAST 10 DAYS BUT THE RASH HAS NOT SUBSIDED. AS HIS PHYSICIAN SUSPECTS AN ALLERGIC REACTION, AN ALLERGY TEST WAS RECOMMENDED. THE SCS SYSTEM REMAINS IMPLANTED AT THIS TIME. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 44C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3245 2838257

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention