BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3810586 · Received May 6, 2014

    Report

    Report Number
    1627487-2014-10104
    Event Type
    Injury
    Date Received
    May 6, 2014
    Date of Event
    September 4, 2013
    Report Date
    April 18, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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

    THE PT (B)(6) WAS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED THE PT EXPERIENCED PAIN AT THE IPG SITE. THE PT WAS HOSPITALIZED FROM (B)(6) 2013, DURING WHICH TIME, THE IPG WAS EXPLANTED AND REPLACED WITH A SMALLER IPG. THE NEW IPG WAS IMPLANTED IN A NEW SITE WHICH RESOLVED THE REPORTED ISSUE. IT WAS NOTED THE PT WAS STILL RECEIVING STIMULATION PRIOR TO THE PROCEDURE. PLEASE NOTE: ADDITIONAL DEVICE INFO HAS BEEN REQUESTED; HOWEVER, NO FURTHER INFO WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271585 UNK SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization