BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S-8 LEAD KIT, 60CM LENGTH

    MDR report key: 4860599 · Received June 22, 2015

    Report

    Report Number
    1627487-2015-32348
    Event Type
    Injury
    Date Received
    June 22, 2015
    Date of Event
    May 29, 2015
    Report Date
    June 1, 2015
    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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UDI (DI): (B)(4). 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. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT DESIRED BETTER STIMULATION COVERAGE OF HER PAIN AREA. SUBSEQUENTLY, THE PATIENT UNDERWENT SURGICAL INTERVENTION ON (B)(6) 2015, WHERE AN ADDITIONAL LEAD WAS IMPLANTED. IT WAS ALSO REPORTED DURING THE PROCEDURE, THE PHYSICIAN ELECTIVELY EXPLANTED AND REPLACED THE PATIENT'S IPG WITH A DIFFERENT MODEL. THE PATIENT REPORTEDLY EXPERIENCED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402680 LAMITRODE S-8 LEAD KIT, 60CM LENGTH SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3286 3423022

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Other MODEL 3788, SCS IPG| MODEL 3383, SCS EXTENSION| MODEL 1194 (2), SCS ANCHOR