BEUDAMED
    FDA Adverse Event Injury Summary report: N

    60-CM LENGTH PENTA LEAD

    MDR report key: 2230427 · Received August 15, 2011

    Report

    Report Number
    1627487-2011-07056
    Event Type
    Injury
    Date Received
    August 15, 2011
    Date of Event
    February 28, 2011
    Report Date
    July 18, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROSTIMULATION
    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 A SCS SYSTEM ON (B)(6) 2011. IT WAS REPORTED ON (B)(6) 2011 THAT SINCE THE DAY OF IMPLANT THE PT HAS NOT BEEN ABLE TO RECEIVE STIMULATION IN THE LEFT HIP AND OUTER THIGH. PT HAS BEEN EXPERIENCING STIMULATION BELOW THE KNEES AND RIB AREA. ATTEMPTS TO CORRECT THE REPORTED ISSUE WITH REPROGRAMMING HAVE BEEN SUCCESSFUL. 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 - NEUROSTIMULATION 3228 3246147

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT DATE: