BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3231505 · Received July 12, 2013

    Report

    Report Number
    1627487-2013-12943
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    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 3 OF 3. REFERENCE MFR REPORT: 1627487-2013-12920, 1627487-2013-12942. IT WAS REPORTED THE PATIENT'S IPG IS UNABLE TO COMMUNICATE WITH EXTERNAL DEVICES. A NEW CHARGER WAS ALSO UNABLE TO COMMUNICATE. THE PATIENT ALSO REPORTED THE STIMULATION HAS BEEN GETTING WEAKER AND IS NOT INCREASED WHEN THE AMPLITUDE IS INCREASED. SURGICAL INTERVENTION IS PLANNED AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323695 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3456429

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other SCS ANCHORS: MODEL 1192(2)| IMPLANT DATE: