BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL IPG

    MDR report key: 2212576 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-08039
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Removal / Correction Number
    1627487-05242011-002-R
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IPG SERIAL NUMBER IS INCLUDED IN A FIELD ADVISORY. EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. AFTER EVALUATING THE DEVICE, THE COMPLAINT FOR "NO COMMUNICATION" WAS CONFIRMED. AS RETURNED, THE IPG WOULD NOT COMMUNICATE DUE TO A DEPLETED BATTERY. THE IPG WAS REMOVED. NO VISIBLE ANOMALIES AND NO SIGNS OF LEAKING WERE OBSERVED. WHEN THE BATTERY WAS RECOVERED, THE IPG COMMUNICATED AND PASSED ALL TESTS. CONCLUSION: 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 SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT TWO DIFFERENT CHARGERS WERE UNABLE TO COMMUNICATE WITH THE PT'S IPG. THE PT NOTED THAT THE IPG HAD NOT BEEN CHARGED SINCE (B)(6) 2011. THE IPG WAS REMOVED AND REPLACED BY A NEW IPG. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI 16-CHANNEL IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 2794640

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS LEAD: MODEL 3214| IMPLANT: