BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 2940581 · Received January 29, 2013

    Report

    Report Number
    1627487-2013-15115
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 8, 2013
    Report Date
    January 8, 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 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 DURING A PERMANENT IMPLANT PROCEDURE, LEAD DIAGNOSTICS FOLLOWING PLACEMENT OF A SURGICAL LEAD FOUND HIGH IMPEDANCE MEASUREMENTS FOR SEVERAL CONTACTS. THE PHYSICIAN INDICATED HE BELIEVED THE IMPEDANCE TO BE CAUSED BY PATIENT ANATOMY AND THE TISSEL THAT WAS USED. THE PHYSICIAN STATED HE WANTED TO GIVE THE PATIENT TIME TO HEAL AFTER THE PROCEDURE. THE SJM REP MET WITH THE PATIENT APPROX EIGHT DAYS AFTER THE PROCEDURE AND INDICATES ALL IMPEDANCE ARE NORMAL AND THE PATIENT REPORTS EFFECTIVE STIMULATION IS BEING RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39653 PENTA SCS LEAD LGW ST. JUDE MEDICAL- NEUROMODULATION 3228 3829788

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR