BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON RECHARGEABLE IPG

    MDR report key: 2130669 · Received June 14, 2011

    Report

    Report Number
    1627487-2011-01650
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 10, 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

    MANUFACTURER'S EVALUATION: THE RETURNED PRODUCT WAS NOT ANALYZED AS THERE WAS NO ALLEGED DEVICE COMPLAINT THAT COULD BE CONFIRMED VIA LABORATORY TESTING. SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, ON (B)(6) 2008. IT WAS REPORTED THAT THE PATIENT'S SYSTEM WAS EXPLANTED ON (B)(6) 2011. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON RECHARGEABLE IPG TOTALLY IMPLANTABLE PULSE GENERATOR LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 118928

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANTED:| IMPLANTED:| SCS LEAD: MODEL 3146 (X2)| SCS LEAD: MODEL 3186