BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY

    MDR report key: 4093585 · Received September 4, 2014

    Report

    Report Number
    1627487-2014-21584
    Event Type
    Injury
    Date Received
    September 4, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 7, 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 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

    DEVICE 1 OF 2. REFERENCE MFR. REPORT: 1627487-2014-21585. THE PATIENT (B)(6) IS ENROLLED IN A CLINICAL STUDY. IT WAS REPORTED DURING POST-OPERATIVE PROGRAMMING, DIAGNOSTICS INDICATED A "CONNECTION" ISSUE. AS A RESULT, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2014 AND IT WAS NOTED THE LEAD WAS NOT FULLY INSERTED INTO THE IPG HEADER. THE IPG/LEAD CONNECTION WAS RESTORED AS A RESULT OF THE PROCEDURE. IT WAS REPORTED THE PHYSICIAN EXPERIENCED DIFFICULTY INSERTING THE LEAD INTO THE HEADER AT THE IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    541499 PRODIGY SCS IPG GZB ST. JUDE MEDICAL - NEUROMODULATION 3799 4242446

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other