BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 44

    MDR report key: 4132677 · Received September 24, 2014

    Report

    Report Number
    1627487-2014-24221
    Event Type
    Injury
    Date Received
    September 24, 2014
    Date of Event
    August 18, 2014
    Report Date
    September 2, 2014
    Manufacturer
    ST. JUDE MEDICAL ¿ NEUROMODULATION
    Product Code
    GZB
    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: 1627487-2014-24222. IT WAS REPORTED THE PATIENT IS EXPERIENCING INEFFECTIVE STIMULATION. X-RAYS REVEALED THE LEAD WAS LOCATED ON THE MIDLINE. SURGICAL INTERVENTION MAY TAKE PLACE AT A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595889 LAMITRODE 44 SCS LEAD GZB ST. JUDE MEDICAL ¿ NEUROMODULATION 3244 4112197

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3788