BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC CONVENTIONAL IPG

    MDR report key: 2092870 · Received May 11, 2011

    Report

    Report Number
    1627487-2011-01511
    Event Type
    Injury
    Date Received
    May 11, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 15, 2011
    Manufacturer
    ST. JUDE MEDICAL-NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 (B)(6) REC'D HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELT A BURNING SENSATION AT THE IPG POCKET SITE. THE PT REPORTED THAT THE PAIN COMES AND GOES WHETHER STIMULATION IS ON OR OFF. THE PHYSICIAN EXPLANTED AND REPLACED THE IPG ON (B)(6) 2011. IT WAS REPORTED THAT THE PT WAS PROGRAMMED ONE HOUR POSTOPERATIVE, AND THE ISSUE DID NOT RECUR. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC CONVENTIONAL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL-NEUROMODULATION 3688 3100739

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention