BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPOLE 16 60-CM LENGTH PADDLE LEAD

    MDR report key: 2182216 · Received July 7, 2011

    Report

    Report Number
    1627487-2011-03231
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 8, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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) 2011. IT WAS REPORTED THAT THE PT HAD SEIZURES WITHIN DAYS OF IMPLANTATION OF THE SYSTEM. THE PT ALSO ADMITTED THAT HE HAD BEEN TAKING MEDICATION FOR THE SEIZURE. FOLLOW UP WITH THE PT FOUND THE PT IS MOVING TO ANOTHER STATE AND PLANS TO CONSULT A NEUROLOGIST FOR THE BEST COURSE OF ACTION. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 16 60-CM LENGTH PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION 3219 3252801

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT: