BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 4024449 · Received August 12, 2014

    Report

    Report Number
    1627487-2014-08191
    Event Type
    Injury
    Date Received
    August 12, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    ST JUDE MED - 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 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

    IT WAS REPORTED THE PT'S SCS LEAD INCISION SITE IS OPEN, AND THE LEAD TAIL CAN BE SEEN. THE PT WILL FOLLOW-UP WITH HIS SURGEON TO DETERMINE THE NEXT STEPS TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479000 PENTA SCS LEAD GZB ST JUDE MED - NEUROMODULATION 3228 4468705

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other IMPLANT DATE:| SCS EXTENSION, MODEL 3386| SCS IPG, MODEL 3789| IMPLANT DATE: