BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3060388 · Received April 11, 2013

    Report

    Report Number
    1627487-2013-05519
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 18, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULTION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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 HAS BEEN EXPERIENCING INADEQUATE COVERAGE SINCE FALLING. THE PT WILL UNDERGO X-RAYS FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156572 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULTION 3228 3593621

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3788| IMPLANTED: