BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SINGLE EXTENSION

    MDR report key: 3891690 · Received June 9, 2014

    Report

    Report Number
    1627487-2014-25425
    Event Type
    Injury
    Date Received
    June 9, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 19, 2014
    Manufacturer
    ST JUDE MODULATION - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3 OF 3. REFERENCE MFR REPORT # 1627487-2014-25423 AND 1627487-2014-25424. IT WAS REPORTED THAT THE PATIENT IS NO LONGER RECEIVING STIMULATION. REPROGRAMMING DID NOT PROVIDE RESOLUTION. DIAGNOSTICS REVEALED NO ANOMALIES. X-RAYS IDENTIFIED THE PATIENT MAY HAVE A POSSIBLE BREAK IN AN EXTENSION. IN TURN, THE PATIENT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    336132 SINGLE EXTENSION SCS EXTENSION GZB ST JUDE MODULATION - NEUROMODULATION 3383 3554451

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other SCS IPG: MODEL 3788,| IMPLANT DATE: