BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 3162407 · Received June 6, 2013

    Report

    Report Number
    1627487-2013-04723
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    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 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 HAD COMPLAINED THAT ONLY 90% OF HIS PAIN HAD BEEN COVERED BY THE SCS SYSTEM STIMULATION; THE PATIENT EXPECTED 100% COVERAGE. THE SJM REPRESENTATIVE MET WITH THE PATIENT FOR REPROGRAMMING BUT WAS UNABLE TO OBTAIN FULL BILATERAL COVERAGE. IT WAS REPORTED THE PATIENT WAS SCHEDULED FOR A CT SCAN, AND WILL WORK WITH THE PHYSICIAN REGARDING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251394 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3861993

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention IMPLANT DATE:| SCS IPG, MODEL 3788