BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C SURGICAL LEAD

    MDR report key: 2051330 · Received April 7, 2011

    Report

    Report Number
    1627487-2011-01358
    Event Type
    Injury
    Date Received
    April 7, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    THE PT REC'D HER SCS SYS, INCLUDING A SURGICAL LEAD, ON (B)(6) 2007. IT WAS REPORTED THAT THE PT REPORTED DISCOMFORT WITH HER STIMULATION. SHE REQUESTED TO BE REPROGRAMMED AND STATED THAT SHE HAD NOT USED HER STIMULATOR IN A COUPLE OF YEARS. F/U ON THE PT FOUND THAT SHE REPORTED THAT STIMULATION WAS VERY COMFORTABLE AFTER BEING REPROGRAMMED. NO FURTHER PT ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 16C SURGICAL LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3214 67489

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SCS IPG: MODEL 3716| IMPLANT: