BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON

    MDR report key: 3134032 · Received May 23, 2013

    Report

    Report Number
    1627487-2013-08138
    Event Type
    Injury
    Date Received
    May 23, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 1, 2013
    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

    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

    IT WAS REPORTED THE PT'S IPG (IMPLANTABLE PULSE GENERATOR) WAS SUPERFICIAL AND HE HAD BUMPED THE IPG SITE WHICH HAD CAUSED IT TO BE SORE. FOLLOW-UP INFORMATION SUGGESTED THE PT HAD THE IPG REPOSITIONED TO ADDRESS THE ISSUE ON (B)(6) 2013. THE PT WAS TO BE SCHEDULED FOR A FOLLOW-UP IN 2 WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229123 EON SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3716 3319792

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS EXTENSION: MODEL 3346(2)| IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3169(2)| IMPLANT DATE:| SCS LEAD: MODEL 3166(2)