BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2903047 · Received January 3, 2013

    Report

    Report Number
    1627487-2013-15012
    Event Type
    Injury
    Date Received
    January 3, 2013
    Date of Event
    November 15, 2012
    Report Date
    December 5, 2012
    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 PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT IS NOT RECEIVING EFFECTIVE STIMULATION COMPARED TO STIMULATION RECEIVED DURING HER TRIAL. REPROGRAMMING WAS ABLE TO PROVIDE PARTIAL COVERAGE. PATIENT INDICATED STIMULATION CAUSES PAIN IN HER RIGHT KNEE AND RIB. FOLLOW UP INDICATED THE PATIENT DOES NOT DESIRE ANY INTERVENTION PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3716 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3605344

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: