BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 2875161 · Received December 13, 2012

    Report

    Report Number
    1627487-2012-14177
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    October 15, 2012
    Report Date
    November 19, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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 OBSERVED A "IPG BATTERY LOW, SEE PHYSICIAN" WARNING. THE PT'S IPG WAS REPLACED WITH A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 2798818

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186 (2)| SCS ANCHOR: MODEL 1194 (2)