BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 8

    MDR report key: 2894865 · Received December 20, 2012

    Report

    Report Number
    1627487-2012-02855
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    March 21, 2012
    Report Date
    March 21, 2012
    Manufacturer
    ST. JUDE MEDICLA - NEUROMODULATION
    Product Code
    LGW
    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 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

    IT WAS REPORTED THE PT'S LEAD EXHIBITED HIGH IMPEDANCE READINGS. THE PHYSICIAN EXPLANTED AND REPLACED THE LEAD WITH A DIFFERENT MODEL ON (B)(6) 2012.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE TRIPOLE 8 SCS LEAD LGW ST. JUDE MEDICLA - NEUROMODULATION 3208 55543

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR IMPLANT DATE:| SCS IPG: MODEL 3688