BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 2843441 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-02666
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 22, 2012
    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

    EVALUATION: RESULTS: THE COMPLAINT FOR INVALID IMPEDANCES WAS NOT CONFIRMED. AS RECEIVED, MICROSCOPIC INSPECTION REVEALED THE LEAD WAS IN GOOD CONDITION. THE LEAD PASSED ALL FUNCTIONAL AND CONTINUITY TESTING. 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 1 OF 2. REFERENCE MFR REPORT: 1627487-2012-02667. THE PATIENT RECEIVED TWO SURGICAL LEADS AS PART OF HER SCS SYSTEM. IT WAS REPORTED ONE OF THE LEADS WAS BEING REVISED IN ORDER TO ADJUST ITS PLACEMENT. THE LEAD EXHIBITED INVALID IMPEDANCE READINGS AND TROUBLESHOOTING EFFORTS DURING THE PROCEDURE ALLEGEDLY WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PHYSICIAN DECIDED TO EXPLANT AND REPLACE THE LEAD. BOTH OF THE LEADS ARE BEING REPORTED AS THE AFFECTED DEVICE IS UNDETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3463354

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention SCS IPG: MODEL 3788| IMPLANT:| IMPLANT:| SCS ANCHOR: MODEL 1192