BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2152590 · Received June 27, 2011

    Report

    Report Number
    1627487-2011-01689
    Event Type
    Malfunction
    Date Received
    June 27, 2011
    Date of Event
    May 29, 2011
    Report Date
    May 29, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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 A PERCUTANEOUS LEAD, ON (B)(6) 2007, FOR HEADACHES (OFF-LABEL). IT WAS REPORTED THAT THE PATIENT WILL INCREASE THE AMPLITUDE TO THE HIGHEST LEVEL USING HER PROGRAMMER; HOWEVER, THE STIMULATION IS NO LONGER EFFECTIVE. THE PATIENT PLANS TO MEET WITH HER PHYSICIAN REGARDING THIS ISSUE. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST. JUDE MEDICAL - NEUROMODULATION 3186 64148

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Required Intervention SCS IPG: MODEL 3608| IMPLANT: