BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2182602 · Received July 5, 2011

    Report

    Report Number
    1627487-2011-01708
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 6, 2011
    Report Date
    June 6, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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

    THE PT RECEIVED HIS SCS SYSTEM, INCLUDING TWO PERCUTANEOUS LEADS (FROM THE SAME LOT), ON (B)(6) 2010. IT WAS REPORTED THAT THE PT WAS UNABLE TO TURN UP HIS AMPLITUDE ON HIS PROGRAMMER. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 3062371

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: