BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON RECHARGEABLE IPG, 16-CHANNEL

    MDR report key: 2102845 · Received April 12, 2011

    Report

    Report Number
    1627487-2011-00658
    Event Type
    Malfunction
    Date Received
    April 12, 2011
    Date of Event
    April 14, 2011
    Report Date
    April 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED AN SCS SYSTEM INCLUDING AN IPG ON (B)(6) 2006. IT WAS REPORTED THAT ALTHOUGH THE PATIENT HAS STIMULATION, SHE IS EXPERIENCING DIFFICULTY MAINTAINING COMMUNICATION WITH HER IPG VIA THE CHARGING SYSTEM. IN AN EFFORT TO RESOLVE THIS MATTER, A SPACER KIT WAS SHIPPED TO THE PATIENT. FOLLOW-UP ON THIS ISSUE FOUND THAT THE REPORTED PROBLEM PERSISTS WITH USE OF THE NEW MATERIAL. FURTHER INTERROGATION HAS BEEN RECOMMENDED. NO FURTHER INFORMATION IS AVAILABLE.

    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 3716 64532

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS LEAD: MODEL 3288| IMPLANT: