BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MPN MINI

    MDR report key: 4134889 · Received September 25, 2014

    Report

    Report Number
    1627487-2014-25623
    Event Type
    Injury
    Date Received
    September 25, 2014
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    IT WAS REPORTED THE PT (B)(6) WAS EXPERIENCING DISCOMFORT (ACHING) AT THE IPG. ADDITIONALLY, IT WAS REPORTED A PLASTER WITH LOCAL ANESTHETICS WAS USED BUT PROVIDED MINIMAL PAIN RELIEF. IN TURN, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO RELOCATE THE IPG TO THE ABDOMINAL AREA WHICH RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    599517 MPN MINI SCS IPG GZB ST JUDE MEDICAL - NEUROMODULATION 3788 4131159

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other SCS ANCHOR: MODEL 1192| IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3183| SCS EXTENSION: MODEL 3383