BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2243908 · Received August 24, 2011

    Report

    Report Number
    1627487-2011-07103
    Event Type
    Malfunction
    Date Received
    August 24, 2011
    Date of Event
    July 28, 2011
    Report Date
    July 28, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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) 2011. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT'S CHARGING SYSTEM WON'T LOCATE THE IPG. THERE ARE NO REPORTED DAMAGES TO DEVICE OR SYSTEM AND PT PROGRAMMER (PP) COMMUNICATES OKAY; HOWEVER, THE IPG BATTERY INDICATES "LOW". A NEW CHARGING SYSTEM WAS SENT TO THE PT FOR REPLACEMENT. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16 - CHANNEL RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3319782

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention SCS LEAD ANCHOR: MODEL 1192 (2)| SCS LEAD: MODEL 3186 (2)