BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE 60-CM LENGTH PERCUTANEOUS LEADS

    MDR report key: 2201568 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-04002
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    THE PATIENT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS ON (B)(6) 2010. THE PATIENT REPORTED STIMULATION INCREASING WHEN HE LIES DOWN. THE PATIENT HAS BEEN SCHEDULED FOR REPROGRAMMING. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 60-CM LENGTH PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEADS LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3199482

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT: