BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI IPG, 16-CHANNEL RECHARGEABLE

    MDR report key: 2010933 · Received March 4, 2011

    Report

    Report Number
    1627487-2011-00284
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    July 30, 2010
    Report Date
    May 18, 2015
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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.

    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

    DEVICE 1 OF 2 REFERENCE MFR REPORT # 1627487-2015-00039 A REVIEW OF THE PATIENT'S MEDICAL RECORD INDICATED THAT PRIOR TO THE EXPLANT AND REPLACEMENT OF THE IPG, THE PATIENT EXPERIENCED LEAD MIGRATION IN (B)(6) 2009 AFTER MOVING A LARGE OBJECT. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2009 TO EXPLANT AND REPLACE THE PATIENT¿S LEADS (FROM THE SAME LOT) AND REVISE THE IPG. IT WAS NOTED DURING THE PROCEDURE THE PHYSICIAN IDENTIFIED A FRACTURE IN ONE OF THE LEADS. AN ADDITIONAL REPORT IS BEING SUBMITTED FOR THE PATIENT'S LEADS.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH AN IPG ON (B)(6) 2009. IT WAS REPORTED THAT THE PT FELT A BURNING SENSATION AT THE IPG SITE WHEN HER STIMULATION WAS IN USE. IN AN EFFORT TO RESOLVE THIS MATTER, THE PT'S IPG WAS REPLACED ON (B)(6) 2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG, 16-CHANNEL RECHARGEABLE TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3788 2803493

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention