BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2052078 · Received March 1, 2011

    Report

    Report Number
    1627487-2011-00265
    Event Type
    Malfunction
    Date Received
    March 1, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 1, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    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 WAS IMPLANTED WITH AN IPG ON (B)(6) 2010. IT WAS REPORTED THAT HE SUDDENLY LOST STIMULATION AFTER BENDING DOWN. THE PT WAS ABLE HOWEVER TO INITIATE THERAPY AFTER SQUATTING MULTIPLE TIMES. A CONSULTATION HAS BEEN SCHEDULED FOR FURTHER INTERROGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG, 16-CHANNEL TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIV. 3716 3133004

    Patients

    Seq Age Sex Outcome Treatment
    1