BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60-CM LENGTH PENTA LEAD

    MDR report key: 2212592 · Received August 11, 2011

    Report

    Report Number
    1627487-2011-07042
    Event Type
    Injury
    Date Received
    August 11, 2011
    Date of Event
    July 13, 2011
    Report Date
    July 13, 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 AN SCS SYSTEM ON (B)(6) 2010. IT WAS REPORTED ON (B)(6) 2011 THAT THE PT FEELS STIMULATION IN THE WRONG LOCATION. THE PT'S PAIN PATTERN IS LOW BACK, BUTTOCK, RIGHT LEG. IMPEDANCE READINGS FOUND SEVERAL CONTACTS WERE READING HIGH. ATTEMPTS TO PROGRAM AROUND THE CONTACTS CONTINUED TO RESULT IN ABDOMINAL STIMULATION. AN X-RAY WAS REQUESTED. THERE IS NO RECORD OF PT FALLING OR ANY TRAUMA. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 60-CM LENGTH PENTA LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3228 3213684

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: