BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 4

    MDR report key: 3960163 · Received July 23, 2014

    Report

    Report Number
    1627487-2014-26587
    Event Type
    Injury
    Date Received
    July 23, 2014
    Date of Event
    June 30, 2014
    Report Date
    June 30, 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 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

    DEVICE 3 OF 3. REF MFR REPORTS: 1627487-2014-26583, 26586. IT WAS REPORTED THE PT WAS UNABLE TO COMMUNICATE WITH HIS PROGRAMMER OR CHARGER. THE PT COMPLETELY RECHARGED HIS IPG THE END OF (B)(6) 2014 AND THE FIRST WEEK OF (B)(6) 2014 HE LOST THE ABILITY TO COMMUNICATE WITH EXTERNAL DEVICES. IN ADDITION, THE PT IS NO LONGER RECEIVING EFFECTIVE STIMULATION. THE PT DENIES ANY TRAUMA. A SJM REP WAS UNABLE TO COMMUNICATE THE IPG WITH ANY EXTERNAL DEVICES AND THUS WAS UNABLE TO PERFORM LEAD DIAGNOSTICS. SURGICAL INTERVENTION IS PENDING TO ADDRESS THESE ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429836 LAMITRODE 4 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3240 3148207

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other