BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAMITRODE TRIPOLE 16C

    MDR report key: 3931722 · Received June 23, 2014

    Report

    Report Number
    1627487-2014-03442
    Event Type
    Injury
    Date Received
    June 23, 2014
    Date of Event
    June 17, 2014
    Report Date
    June 17, 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
    TX, US
    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 WHILE THE PATIENT WAS IN RECOVERY FOLLOWING AN SCS IPG REVISION (REFERENCE MFR. REPORT: 1627487-2014-03441), THE LEAD DEVELOPED INVALID IMPEDANCE. SURGICAL INTERVENTION WILL BE TAKEN AT A LATER DATE TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    366847 LAMITRODE TRIPOLE 16C SCS LEAD GZB ST. JUDE MEDICAL - NEUROMODULATION 3214 3255437

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other IMPLANT DATE:| SCS IPG, MODEL: 3789