BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI RECHARGEABLE IPG

    MDR report key: 2133474 · Received June 15, 2011

    Report

    Report Number
    1627487-2011-01651
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: 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. 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

    DEVICE 1 OF 3. REFERENCE MFR REPORT: 1627487-2011-01652 AND 1627487-2011-01653. THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED THAT THE PT HAD DEVELOPED AN INFECTION AT THE IPG POCKET SITE. CULTURE RESULTS SHOWED (B)(6), AND THE PT WAS TREATED WITH (B)(6). IT WAS REPORTED THAT THE PT HAD BEEN (B)(6) (B)(6) AGO. F/U ON THE PT FOUND THAT THE PT'S SYSTEM WAS EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MFR FOR ANALYSIS. ATTEMPTS TO OBTAIN ADD'L INFO REGARDING THE PT'S CONDITION WERE UNSUCCESSFUL.

    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 3202971

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention