BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS QUAD LEAD 3/4MM, 30CM

    MDR report key: 2121035 · Received June 9, 2011

    Report

    Report Number
    1627487-2011-00800
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 12, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    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 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 3 OF 4: REFERENCE MFR. REPORT #S 1627487-2011-00798, 1627487-2011-00799 AND 1627487-2011-00801. THE PT RECEIVED AN SCS SYSTEM INCLUDING THREE PERCUTANEOUS LEADS FROM DIFFERENT LOTS AND A LEAD EXTENSION. IT WAS REPORTED THAT THE PT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL LEAD CONTACTS. EFFORTS TO RECAPTURE EFFECTIVE THERAPY VIA REPROGRAMMING PROVED UNSUCCESSFUL. SURGICAL INTERVENTION WAS UNDERTAKEN TO REPLACE THE PT'S LEADS AND EXTENSION. EFFECTIVE THERAPY WAS RECAPTURED AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS QUAD LEAD 3/4MM, 30CM SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 4143 2844859

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention SCS IPG: MODEL 3788| IMPLANTED: