BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY

    MDR report key: 4092202 · Received September 3, 2014

    Report

    Report Number
    1627487-2014-23567
    Event Type
    Injury
    Date Received
    September 3, 2014
    Date of Event
    August 8, 2014
    Report Date
    August 8, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    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

    THIS PT IS A PARTICIPANT IN A CLINICAL STUDY. IT WAS REPORTED AFTER A PERMANENT IPG IMPLANT PROCEDURE, THE PT (B)(6) MET WITH THE SJM REPRESENTATIVE TO HAVE THE DEVICE TURNED ON. HOWEVER, UPON INTERROGATION OF THE DEVICE, IT WAS DETERMINED THAT THERE WAS A CONNECTION ISSUE. AS A RESULT, THE PT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 TO CHECK THE CONNECTION. DURING THE PROCEDURE, IT WAS FOUND THAT THE LEAD WAS NOT FULLY INSERTED INTO THE IPG HEADER. THE LEAD WAS THEN INSERTED INTO THE IPG HEADER. THE LEAD WAS THEN INSERTED INTO THE IPG HEADER, WHICH RESOLVED THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535380 PRODIGY SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3799 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Other SCS LEAD: MODEL 3228| IMPLANT DATE: