BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLAIM 8

    MDR report key: 2871452 · Received December 5, 2012

    Report

    Report Number
    1627487-2012-13167
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 9, 2012
    Report Date
    November 9, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    K072462
    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

    REFERENCE MFR. REPORT: 1627487-2012-13154, 1627487-2012-13155. THERE ARE THREE LEADS FROM THE SAME LOT NUMBER AND TWO LEADS FROM TWO DIFFERENT LOT NUMBERS. IT IS UNKNOWN WHICH LEAD IS RELATED TO THIS EVENT, SUBMITTING REPORTS FOR ALL THREE. IT WAS REPORTED THE PATIENT HAD LEADS IMPLANTED PERIPHERALLY (OFF-LABEL). HALF OF THE CONTACTS ON THE LEFT LEAD HAD INVALID IMPEDANCE. A SJM REPRESENTATIVE TO FOLLOW-UP WITH PATIENT TO SEE IF THE IMPEDANCES HAVE DECREASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLAIM 8 SCS LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3225 3643188

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention SCS EXTENSION: MODEL 3341| SCS IPG: MODEL 3688| IMPLANT DATE:| IMPLANT DATE: