BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTA SURGICAL LEAD

    MDR report key: 2220256 · Received August 16, 2011

    Report

    Report Number
    1627487-2011-01844
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    April 25, 2011
    Report Date
    July 21, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 (B)(6) RECEIVED AN SCS SYSTEM, INCLUDING A SURGICAL LEAD, ON (B)(6) 2011. IT WAS REPORTED THAT THE PT COMPLAINED OF COLD SENSATIONS IN BOTH LEGS AND FEET WHEN STIMULATION WAS TURNED ON. THE PT WAS REPROGRAMMED ON (B)(6) 2011, AND THE ISSUE RESOLVED. NO FURTHER PT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3161293

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention IMPLANT:| SCS IPG: MODEL 3688