BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTA 60-CM LENGTH PADDLE LEAD

    MDR report key: 2193108 · Received July 21, 2011

    Report

    Report Number
    1627487-2011-04003
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 25, 2011
    Report Date
    June 27, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 ON (B)(6) 2011. PT REPORTED PRESSURE OR DISCOMFORT AROUND THE AREA WHERE THE LEADS MAY BE SITUATED (B)(6) AFTER THE PROCEDURE. IT WAS REPORTED THAT THE STIMULATION IS TAKING CARE OF HIS CHRONIC PAIN AND THE PHYSICIAN ADVISED IT WAS LIKELY DUE TO THE HEALING PROCESS, NOT DUE TO THE DEVICE. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENTA 60-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3333115

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention IMPLANT:| SCS IPG: MODEL 3788