BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88

    MDR report key: 3223039 · Received July 10, 2013

    Report

    Report Number
    1627487-2013-15938
    Event Type
    Injury
    Date Received
    July 10, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    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 INFORMATION 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

    DEVICE 1 OF 2. REFERENCE MFR REPORT: 1627487-2013-15939. IT WAS REPORTED THE PATIENT WAS EXPERIENCING INEFFECTIVE STIMULATION ON HER RIGHT SIDE. SURGICAL INTERVENTION WAS UNDERTAKEN AND THE PHYSICIAN ATTEMPTED TO REPOSITION THE LEAD BUT WAS UNSUCCESSFUL. THE PHYSICIAN THEN ATTEMPTED TO PLACE A MODEL 3286 LEAD BUT WAS ALSO UNSUCCESSFUL DUE TO THE EXISTING LEAD PUSHING THE MODEL 3286 LEAD TO THE RIGHT. THE PHYSICIAN THEN EXPLANTED AND REPLACED THE PATIENT'S EXISTING LEAD. THE SURGICAL PROCEDURE WAS EXTENDED BY 1 HOUR. THE PATIENT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    316007 LAMITRODE 88 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 3590609

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Other SCS ANCHOR: MODEL 1192| SCS IPG: MODEL 3716| IMPLANT:| IMPLANT: