BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE S8

    MDR report key: 3012271 · Received March 12, 2013

    Report

    Report Number
    1627487-2013-04309
    Event Type
    Injury
    Date Received
    March 12, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 20, 2013
    Manufacturer
    ST. JUDE MEDICAL - 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 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: 1627487-2013-04308. IT WAS REPORTED THE PT HAD FELT A SHOCKING SENSATION. THE SJM REPRESENTATIVE MET WITH THE PT FOR REPROGRAMMING, AND ALL CONTACTS ON THE LEAD HAD NORMAL IMPEDANCES. IT WAS REPORTED SOME CONTACTS WERE UNABLE TO BE USED DURING REPROGRAMMING. FOLLOW UP IDENTIFIED THE PHYSICIAN REPOSITIONED BOTH LEADS ON (B)(6) 2013. IT WAS REPORTED THE SURGICAL INTERVENTION RESOLVED THE ISSUE, AND THE PT RECEIVED EFFECTIVE STIMULATION POSTOPERATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    104305 LAMITRODE S8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3286 3757707

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention IMPLANTED:| SCS IPG: MODEL 3788| SCS ANCHOR: MODEL 1192 (2)| IMPLANTED: