BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE 88

    MDR report key: 2831241 · Received November 6, 2012

    Report

    Report Number
    1627487-2012-10621
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 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
    UK
    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

    IT WAS REPORTED THE PATIENT ((B)(6)) RECEIVED THE SCS SYSTEM ON (B)(6) 2012. INTRA-OPERATIVE TESTING WAS PERFORMED WITH NO ANOMALIES NOTED. THREE DAYS FOLLOWING THE PROCEDURE, THE SYSTEM COULD NOT BE PROGRAMMED AND IMPEDANCE ISSUES WERE IDENTIFIED. IT WAS SUSPECTED THE IMPEDANCE ISSUES WERE RELATED TO FLUID COLLECTION AROUND THE CONTACTS. IT WAS DECIDED TO ALLOW TIME TO PASS TO SEE IF THE FLUID SETTLES AND THE ISSUE RESOLVES ON ITS OWN. PLEASE NOTE: DEVICE INFORMATION AND ADDITIONAL DETAILS WERE REQUESTED; HOWEVER, NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LAMITRODE 88 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3288 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention