BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3161516 · Received June 5, 2013

    Report

    Report Number
    1627487-2013-04711
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    February 13, 2013
    Report Date
    May 14, 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 LEAD HAD MIGRATED, AND THE PHYSICIAN OPTED TO EXPLANT THE SCS SYSTEM. THERE WERE NO SJM REPS PRESENT FOR THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249287 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3136517

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE:| SCS ANCHOR: MODEL 1194 (2)| IMPLANT DATE: