BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXXESS QUAD LEAD 3/4MM, 60CM

    MDR report key: 2251273 · Received September 12, 2011

    Report

    Report Number
    1627487-2011-06106
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    KGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS: THE LEAD WAS RETURNED CUT AND INCOMPLETE. AS SUCH NO FUNCTIONAL TESTING COULD BE PERFORMED. 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

    THE PATIENT (NETHERLANDS) WAS IMPLANTED WITH AN SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD ON (B)(6) 2011. DURING THE IMPLANT PROCEDURE, IT WAS ALLEGED THAT THE PHYSICIAN EXPERIENCED DIFFICULTY IMPLANTING THE LEAD EXTENSION (REFERENCE MFR. REPORT #S 1627487-2011-00921 AND 1627487-2011-00922). THE ASSOCIATED LEAD WAS REPORTEDLY REPLACED ON (B)(6) 2011 DUE TO LACK OF STIMULATION. EFFECTIVE THERAPY RELIEF WAS RECAPTURED FOR THE PATIENT AS A RESULT OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AXXESS QUAD LEAD 3/4MM, 60CM SPINAL CORD STIMULATION LEAD KGW ST. JUDE MEDICAL - NEUROMODULATION 4146 3158085

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention IMPLANTED:| SCS LEAD EXTENSION: MODEL 3383| SCS IPG: MODEL UNKNOWN| IMPLANTED: