BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 1934560 · Received November 23, 2010

    Report

    Report Number
    1627487-2010-03304
    Event Type
    Malfunction
    Date Received
    November 23, 2010
    Date of Event
    October 26, 2010
    Report Date
    October 26, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 HER SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION. THE IPG IS UNABLE TO COMMUNICATE WITH THE CHARGER AND THE PT PROGRAMMER. THE PT HAD NOT CHARGED HER IPG IN THE PAST THREE WEEKS PRIOR TO THE EVENT. FOLLOW UP ON THE PT FOUND THAT A REPLACEMENT PROGRAMMER WAS UNSUCCESSFUL IN RESOLVING THE ISSUE. THE PT WAS SCHEDULED FOR A SURGICAL EVALUATION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3716 118457

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention