BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD

    MDR report key: 2210293 · Received August 8, 2011

    Report

    Report Number
    1627487-2011-03393
    Event Type
    Malfunction
    Date Received
    August 8, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 11, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO 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

    THE PT RECEIVED AN SCS SYSTEM ON (B)(6) 2009. IT WAS REPORTED THAT THE PT TURNS THE STIMULATION UP TO 20 BARS AND HE DOES NOT FEEL ANYTHING EXCEPT AT HIS IPG SITE. A FULL DIAGNOSTIC IMPEDANCE MEASUREMENT SHOWED ALL CONTACTS EXHIBITED NORMAL IMPEDANCES. AN X-RAY SHOWED ONE LEAD WAS WRAPPED AROUND THE IPG. THE OTHER LEAD HAS NOT MIGRATED. A REPOSITIONING OF THE LEAD IS PLANNED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUATTRODE 30-CM LENGTH PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3163 2186109

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| SCS LEAD: MODEL 3186| SCS IPG: MODEL 3788