BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 4142864 · Received September 23, 2014

    Report

    Report Number
    1627487-2014-08308
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 5, 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

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT WERE FOUND. 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 3 OF 4. REFERENCE MFR REPORT # 1627487-2014-08306, 08307, 08309. IT WAS REPORTED THE PT HAS AN OPEN WOUND NEAR HIS SCS LEAD AND EXTENSION SITES WITH THE LEADS VISIBLE AND DRAINAGE OCCURRING. THE PT WAS PRESCRIBED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    590937 SINGLE EXTENSION SCS EXTENSION GZB ST. JUDE MEDICAL - NEUROMODULATION 3383 3720315

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Other IMPLANT DATE:| SCS IPG: MODEL 3788