BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3940442 · Received June 18, 2014

    Report

    Report Number
    1627487-2014-21404
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 27, 2014
    Manufacturer
    ST JUDE MEDICAL - 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 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 2 OF 2. REFER TO MFR REPORT 1627487-2014-21403. IT WAS REPORTED THAT THE PATIENT EXPERIENCED INEFFECTIVE STIMULATION. REPROGRAMMING COULD NOT BE ATTEMPTED AS THE IPG WAS AT 'STIM OFF.' X-RAYS CONFIRMED LEAD MIGRATION AND IT APPEARED THE LEAD MAY HAVE PULLED OUT OF THE IPG HEADER. SURGICAL INTERVENTION WILL BE TAKEN TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    357769 PENTA SCS LEAD GZB ST JUDE MEDICAL - NEUROMODULATION 3228 4391373

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other