BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3012217 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-06044
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 16, 2013
    Report Date
    February 18, 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 HAD BEEN TAKEN TO THE EMERGENCY ROOM DUE TO NUMBNESS FROM HIS KNEES TO TOES. A WORK-UP WAS PERFORMED AND NO ISSUES WERE OBSERVED. THE PT WAS INSTRUCTED TO CALL HIS PHYSICIAN. ALSO, THE PT HAS TURNED THE STIMULATION OFF AND THE ISSUE HAS NOT OCCURRED AGAIN. THE NEXT COURSE OF ACTION HAS NOT BEEN DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104747 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3824599

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R IMPLANT DATE:| SCS LEAD: MODEL 3186| IMPLANT DATE:| SCS IPG: MODEL 3788| IMPLANT DATE:| IMPLANT DATE:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192(X2)