BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA

    MDR report key: 3133342 · Received May 20, 2013

    Report

    Report Number
    1627487-2013-05707
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 23, 2013
    Report Date
    April 24, 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
    CA, 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-05708. IT WAS REPORTED THE PT EXPERIENCED OVERSTIMULATION AT THE LEAD SITE ON SEVERAL OCCASIONS. THE PT WAS UNABLE TO DEACTIVATE STIMULATION WITH THE PROGRAMMER OR MAGNET. THE IPG SHUT OFF BY ITSELF AFTER THE PT EXPERIENCED 30 MINUTES OF OVERSTIMULATION. REPROGRAMMING RESOLVED THE PT'S ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223499 PENTA SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3699751

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT:| SCS ANCHORS: MODEL 1192 (X2)