BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION, 60CM

    MDR report key: 2180682 · Received May 5, 2011

    Report

    Report Number
    1627487-2011-00606
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    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 3 OF 4. REFERENCE MFR REPORT #S 1627487-2011-00604, 00605 AND 00607. THE PT RECEIVED AN SCS SYSTEM FOR RSD OF THE RIGHT ARM INCLUDING AN IPG, TWO PERCUTANEOUS LEADS AND TWO LEAD EXTENSIONS FROM DIFFERENT LOTS. IT WAS REPORTED THAT THE PT FEELS DISCOMFORT WHEN PRESSING OVER THE IPG SITE AND EXPERIENCES HEATING OF THE IPG POCKET WHEN THE DEVICE IS CHARGING. SHE ALSO ALLEGES FEELING STIMULATION IN HER LEFT ARM. IN ADDITION, IT WAS REPORTED THAT THE PT EXPERIENCES A BURNING SENSATION ALONG THE LENGTH OF HER LEAD, PAIN IN BOTH OF HER LEGS AND HEADACHES WHEN HER STIMULATION IS NOT IN USE. A DIAGNOSTIC TEST REVEALED EITHER LOW OR INVALID IMPEDANCE READINGS FOR HER LEAD CONTACTS. EFFECTIVE PAIN COVERAGE WAS CAPTURED VIA REPROGRAMMING; HOWEVER, THIS SITUATION WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, 60CM SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION DIVISION 3386 2791002

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention