BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2260248 · Received August 25, 2011

    Report

    Report Number
    1627487-2011-07147
    Event Type
    Malfunction
    Date Received
    August 25, 2011
    Date of Event
    July 29, 2011
    Report Date
    July 29, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 A SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT HAS STIMULATION BUT THE COMMUNICATION WITH THE IPG IS NOT STEADY. SHE REPORTED THAT ANY SLIGHT MOVEMENT WOULD CAUSE A LOSS OF COMMUNICATION. IT WAS NOTED THE IPG DOES PROTRUDE SOME WHAT. A SPACER KIT WAS SHIPPED TO THE PT. ATTEMPTS TO GATHER ADDITIONAL INFO HAVE BEEN UNSUCCESSFUL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON 16 - CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 173834

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention