BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON PATIENT PROGRAMMER

    MDR report key: 2881398 · Received December 17, 2012

    Report

    Report Number
    1627487-2012-03872
    Event Type
    Injury
    Date Received
    December 17, 2012
    Report Date
    November 20, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT REPORTED UPON TURNING HIS PT PROGRAMMER ON, HE EXPERIENCED THE PROGRAMMER INCREASING TO THE MAXIMUM AMPLITUDE. THE PT WAS ABLE TO TURN THE STIMULATION DOWN TO A COMFORTABLE SETTING. THE ISSUE WAS NOT RESOLVED WITH REPLACING THE BATTERIES OF TH PROGRAMMER. A REPLACEMENT PROGRAMMER WAS SENT TO THE PT. F/U IDENTIFIED THE REPLACEMENT PROGRAMMER RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON PATIENT PROGRAMMER SCS PATIENT PROGRAMMER LGW ST. JUDE MEDICAL - NEUROMODULATION 3851 3454951

    Patients

    Seq Age Sex Outcome Treatment
    1 251 YR Required Intervention