BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2881130 · Received December 14, 2012

    Report

    Report Number
    1627487-2012-14193
    Event Type
    Injury
    Date Received
    December 14, 2012
    Date of Event
    November 26, 2012
    Report Date
    November 26, 2012
    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 1 OF 2. REF MFR REPORT: 1627487-2012-14194. IT WAS REPORTED THE PT EXPERIENCED A WET TAP DURING HER PERMANENT IMPLANT PROCEDURE. THE PT WAS GIVEN A BOLUS OF IV FLUIDS. POST-OPERATIVELY, THE PT HAD NO ASSOCIATED VERY MINIMAL COMPLAINTS. THE PT HAD NO ASSOCIATED COMPLAINTS THE FOLLOWING DAY. THE PT IS RECEIVING EFFECTIVE STIMULATION AND THE ISSUE HAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3715644

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention IMPLANT DATE:| SCS ANCHOR: MODEL 1192 (2)| IMPLANT DATE:| SCS IPG: MODEL 3788