BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIPOLE 60-CM LENGTH SCS PADDLE LEAD

    MDR report key: 2201556 · Received August 4, 2011

    Report

    Report Number
    1627487-2011-04009
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 6, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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

    THE PATIENT RECEIVED HER SCS SYSTEM, INCLUDING PADDLE LEAD ON (B)(6) 2010. THE PATIENT REPORTED SHE HAD STOPPED FEELING STIMULATION. THE PATIENT RECEIVED REPROGRAMMING. DURING REPROGRAMMING, IMPEDANCE ISSUES WERE NOTED WITH SOME CONTACTS ON THE LEAD. STIMULATION WAS REGAINED BY PROGRAMMING AROUND THE CONTACTS WITH IMPEDANCE ISSUES. PATIENT REGAINED STIMULATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIPOLE 60-CM LENGTH SCS PADDLE LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3219 2881381

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention IMPLANT:| EON 16-CHANNEL IPG: MODEL 3716