BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2182257 · Received July 12, 2011

    Report

    Report Number
    1627487-2011-01734
    Event Type
    Malfunction
    Date Received
    July 12, 2011
    Date of Event
    February 1, 2011
    Report Date
    June 13, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PR, 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, INCLUDING AN IPG, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT'S IPG NEEDS TO BE RECHARGED AT LEAST EVERY 24 HOURS. REPROGRAMMING DID NOT RESOLVE THE ISSUE. FOLLOW UP ON THE PT FOUND THAT THE PT REPORTS ADEQUATE STIMULATION AFTER THE BATTERY IS RECHARGED. HOWEVER, THE STIMULATION IS NO LONGER, EFFECTIVE AS THE BATTERY POWER RUNS OUT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    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 3788 3157560

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention