BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2051306 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01348
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    January 3, 2011
    Report Date
    March 11, 2011
    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
    SP
    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 ((B)(6)) RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S IPG REQUIRED FREQUENT REPROGRAMMING SINCE IT APPEARED THAT HER PROGRAMS WERE PERIODICALLY ERASED. THE ISSUE WAS ALLEGEDLY ATTRIBUTED TO THE PT WORKING IN AN AREA WITH AN ELECTROMAGNETIC FIELD. IT WAS REPORTED THAT AT THE LAST REPROGRAMMING SESSION, THE PHYSICIAN WAS UNABLE TO COMMUNICATE WITH THE IPG. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE PT'S IPG ON (B)(6) 2011. F/U ON THE PT FOUND THAT EFFECTIVE STIMULATION WAS CAPTURED POSTOPERATIVE. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV 3788 3075510

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention