BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16 - CHANNEL RECHARGEABLE IPG

    MDR report key: 2191222 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07005
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 30, 2011
    Report Date
    July 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. 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 AN SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED ON (B)(6) 2011 THAT DURING REVISION FOR LEAD MIGRATION (REFER TO MDR# 143413-2011-3349) THE SJM REP COULD NOT COMMUNICATE WITH THE IPG EVEN-THOUGH COMMUNICATION WAS WORKING PRIOR TO SURGERY. MD DECIDED TO REPLACE 3788 WITH ANOTHER 3788, AND COMMUNICATION WITH REPLACEMENT IPG WAS SUCCESSFUL. IT WAS FOUND THAT THERE HAS BEEN PROBLEMS COMMUNICATING WITH THE IPGS IN THIS FACILITY AND SUSPECTS THE FLUORO MACHINE IS CAUSING THE ISSUE. 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 173465

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention SCS LEAD: MODEL 3181| IMPLANTED: