BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EON MINI IPG 16 - CHANNEL IPG

    MDR report key: 2201181 · Received July 29, 2011

    Report

    Report Number
    1627487-2011-07002
    Event Type
    Malfunction
    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
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: CONCLUSION: ANALYSIS OF THE IPG REVEALED NORMAL DEVICE CHARACTERISTICS. THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. 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) 2010. IT WAS REPORTED ON (B)(6) 2011 THAT THE DOCTOR EXPLANTED PT'S SYSTEM ON (B)(6) 2011 BECAUSE OF THE PT'S STATEMENT/COMPLAINT THAT ALTHOUGH DEVICE PROVIDED GOOD COVERAGE, IT DID NOT HELP THEIR PAIN. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI IPG 16 - CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3208628

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention SCS EXTENSION: MODEL 3386| IMPLANTED:| PENTA LEAD| TERMINAL END LEADS: MODEL 3228