BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3110948 · Received May 8, 2013

    Report

    Report Number
    1627487-2013-15608
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    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 PT'S MTS WAS DISPLAYING AN ERROR MESSAGE DURING HIS TRIAL. THE SJM REP MET WITH THE PT AND DIAGNOSTICS INDICATED INVALID IMPEDANCES. THE SJM REP INDICATED THE ISSUE MAY BE DUE TO THE EXTENSIONS. THE PHYSICIAN FELT THE LEAD WAS THE CAUSE OF THE ISSUE AND EXPLANTED AND REPLACED THE LEAD DURING THE PT'S PERMANENT IMPLANT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202216 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3903752

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention IMPLANT DATE:| SCS EXTENSION, MODEL 3386 (2)