BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1940638 · Received December 22, 2010

    Report

    Report Number
    1627487-2010-03858
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    November 26, 2010
    Report Date
    November 26, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, 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 RECEIVED HIS SCS SYSTEM ON (B)(6) 2005. IT WAS REPORTED THAT THE PT FELT PAIN BEHIND THE IPG POCKET SITE. HE STATED THAT HE HAS HAD MULTIPLE ULTRASOUND AND LITHOTRIPSY PROCEDURES FOR KIDNEY STONE TREATMENT DURING THE LAST YR. HE WAS PRESCRIBED ALLOPURINOL TO CONTROL THE CAUSE OF THE KIDNEY STONES. HE REPORTED THAT BEHIND THE IPG SITE IT FELT LIKE A MUSCLE SPASM. HE STATED THAT UPON STANDING, THE PAIN STARTS AT THE BATTERY AND MOVES UP HIS BACK AND DOWN HIS LEG. F/U ON THE PT FOUND THAT HE HAD TURNED STIMULATION OFF AND WAS SCHEDULED TO HAVE SCANS TAKEN. THE PT REPORTED THAT THE PAIN BEHIND THE IPG SITE HAD DIMINISHED BUT WAS STILL PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3716 39813A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention