BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EONC

    MDR report key: 3110815 · Received May 9, 2013

    Report

    Report Number
    1627487-2013-02612
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 15, 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 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: 1627487-2013-02613. IT WAS REPORTED, THE PT EXPERIENCES A SHOOTING PAIN DOWN HIS LEFT LEG WHEN STIMULATION IS ON OR OFF. THE PT'S IPG IS LOCATED IN HIS LEFT FLANK REGION AND HIS NORMAL PAIN PATTERN IS LEFT LEG/FOOT. HE DESCRIBED THE PAIN AS A JOLT OR INTENSE SHOCK THAT IS STRONGER THAN HIS HIGHEST NORMAL AMPLITUDE. HE STATED IF HE PUSHED ON THE IPG AND HIT THE RIGHT SPOT, HE WOULD FEEL THE JOLT DOWN HIS LEG. X-RAYS REVEALED NO ANOMALIES WITH HIS SYSTEM. IT WAS REPORTED, THE PT GETS EXCELLENT PAIN COVERAGE FROM THE SYSTEM BUT HAS SOME RESERVATIONS WITH USING THE SYSTEM. ALLEGEDLY, THE PHYSICIAN IS CONSIDERING SURGICAL INTERVENTION TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202542 EONC SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3688 3563005

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention