BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3891799 · Received June 10, 2014

    Report

    Report Number
    1627487-2014-25436
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 21, 2014
    Report Date
    May 21, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    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 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#: 1627487-2014-25437. IT WAS REPORTED THE PATIENT'S THORACIC INCISION SITE APPEARS TO NOT BE HEALING PROPERLY. ADDITIONALLY, IT WAS STATED THE PATIENT HAS DIABETES. AS A RESULT, THE PHYSICIAN OPENED, EXCISED AND CLOSED THE INCISION ON (B)(6) 2014. FOLLOW-UP REVEALED THE PATIENT'S INCISION IS HEALING AND THE ISSUE IS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338835 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4045097

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other SCS IPG, MODEL: 3788| SCS ANCHORS, MODEL: 1192 (X2)| IMPLANT DATE:| IMPLANT DATE: