BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2862106 · Received November 29, 2012

    Report

    Report Number
    1627487-2012-14107
    Event Type
    Malfunction
    Date Received
    November 29, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 IS NO LONGER RECEIVING STIMULATION FROM HER THORACIC SCS SYSTEM. AN SJM REPRESENTATIVE MET WITH THE PT AND LEAD DIAGNOSTICS WERE NORMAL. REPROGRAMMING WAS UNABLE TO RESOLVE THE ISSUE. FOLLOW UP INFORMATION IDENTIFIED THE PT MET WITH THE IMPLANTING SURGEON AND X-RAYS TAKEN DID NOT SHOW ANY ABNORMALITIES. THE PT DOES NOT WANT TO ADDRESS THE ISSUE AT THIS TIME SINCE SHE IS NOT EXPERIENCING THE SAME AMOUNT OF PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3164427

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL 3788