BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 2564372 · Received May 2, 2012

    Report

    Report Number
    1627487-2012-05640
    Event Type
    Malfunction
    Date Received
    May 2, 2012
    Date of Event
    April 11, 2012
    Report Date
    April 11, 2012
    Manufacturer
    ST. JUDE MED - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    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 2 OF 2. REFERENCE MFR REPORT#: 1627487-2012-05639.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD LGW ST. JUDE MED - NEUROMODULATION 3286 3486370

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention SCS IPG: MODEL: 3788| IMPLANT DATE:| IMPLANT DATE:| SCS ANCHOR: MODEL: 1192 (2)