BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI 16-CHANNEL RECHARGEABLE IPG

    MDR report key: 2153378 · Received June 30, 2011

    Report

    Report Number
    1627487-2011-03155
    Event Type
    Injury
    Date Received
    June 30, 2011
    Date of Event
    March 30, 2011
    Report Date
    June 1, 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

    THIS IPG SERIAL NUMBER IS ASSOCIATED WITH A FIELD ADVISORY. EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFORMATION 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 REC'D AN SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT HAS NOT USED THE SYSTEM IN MONTHS AND IS NO LONGER ABLE TO COMMUNICATE WITH THE IPG VIA EITHER THE CHARGER OR PROGRAMMER. THE SYSTEM WAS EXPLANTED ON (B)(6) 2011. IT WAS REPLACED WITH A NEW IPG. 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 172866

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention