BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3960583 · Received July 21, 2014

    Report

    Report Number
    1627487-2014-21493
    Event Type
    Injury
    Date Received
    July 21, 2014
    Date of Event
    June 25, 2014
    Report Date
    June 25, 2014
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    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: 1627487-2014-21494. IT WAS REPORTED, THE PATIENT ((B)(6)) EXPERIENCED INEFFECTIVE STIMULATION. REPROGRAMMING WAS UNSUCCESSFUL AS UNINTENDED RIGHT SIDE STIMULATION OCCURRED. SUBSEQUENTLY, SURGICAL INTERVENTION TOOK PLACE TO EXPLANT THE LEAD. PER THE PHYSICIAN, THE LEAD WAS VISIBLY FRACTURED. ADDITIONALLY, THE PHYSICIAN EXPERIENCED DIFFICULTY STEERING/ADVANCING THE NEW LEAD (DEVICE 2) IN THE DESIRED LOCATION. AS A RESULT, THE PHYSICIAN ABANDONED THE IMPLANTATION OF THE LEAD AND SUCCESSFULLY IMPLANTED TWO NEW LEADS. THE PROCEDURE WAS EXTENDED BY APPROXIMATELY AN HOUR DUE TO THIS INCIDENT. THE PATIENT RECEIVED EFFECTIVE THERAPY POST-OPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    426573 LAMITRODE S8 SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 4088180

    Patients

    Seq Age Sex Outcome Treatment
    1 Other IMPLANT:| SCS IPG: MODEL 3788| IMPLANT:| SCS EXTENSION: MODEL 3341 (2)| IMPLANT:| SCS LEAD: MODEL 3156(3)