BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2093761 · Received April 14, 2011

    Report

    Report Number
    1627487-2011-01380
    Event Type
    Malfunction
    Date Received
    April 14, 2011
    Date of Event
    March 16, 2011
    Report Date
    March 16, 2011
    Manufacturer
    ST JUDE MEDICAL - NUEROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORDS FOUND A NONCONFORMANCE RELATED TO THE PRODUCT; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE. THE PRODUCT WAS REPLACED AND RELEASED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO 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 PT REC'D HER SCS SYSTEM, INCLUDING A PERCUTANEOUS LEAD, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT LOST STIMULATION. IT WAS REPORTED THAT REPROGRAMMING EFFORTS ARE INITIALLY SUCCESSFUL, BUT AFTER A FEW WEEKS, THE AMPLITUDE AUTO-REDUCES AND THE PT CAN NO LONGER INCREASE THE AMPLITUDE PAST PERCEPTION. THE PHYSICIAN STATED THAT HE WILL MOST LIKELY EXPLANT AND REPLACE THE LEAD WITH A PADDLE LEAD IF THE ISSUE DOES NOT RESOLVE. THE PT IS SCHEDULED FOR A F/U VISIT WITH PHYSICIAN FOR EVAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NUEROMODULATION DIVISION 3186 3229490

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention