BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA

    MDR report key: 2960714 · Received January 25, 2013

    Report

    Report Number
    1627487-2013-04091
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 24, 2012
    Report Date
    January 4, 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 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 STILL HAD EFFECTIVE STIMULATION COVERAGE IN HER BACK AND LEGS, HOWEVER, SHE RECENTLY FELT STIMULATION IN HER ARMS. THE SJM REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING, AND WAS UNABLE TO RESOLVE THE ISSUE. THE PHYSICIAN DISCUSSED INTERVENTION, BUT IT WAS REPORTED THE PT DID NOT WANT TO PURSUE SURGICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35516 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3867355

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention IMPLANT DATE:| SCS IPG: MODEL: 3788