BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 1950392 · Received December 14, 2010

    Report

    Report Number
    1627487-2010-03431
    Event Type
    Malfunction
    Date Received
    December 14, 2010
    Date of Event
    November 14, 2010
    Report Date
    November 16, 2010
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    GZB
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    THE PT RECEIVED HER SCS SYSTEM ON (B)(6) 2008. IT WAS REPORTED THAT THE PT LOST STIMULATION. A DIAGNOSTIC TEST REVEALED LOW IMPEDANCE READINGS ON LEAD CONTACTS 15 AND 16. DURING REPROGRAMMING, LEAD CONTACT 14 WAS USED INSTEAD, AND THE PT REPORTED HER SATISFACTION WITH THE STIMULATION. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES REPORTED. THIS REPORT IS BEING SUBMITTED AS A PRECAUTIONARY MEASURE AS SIMILAR ALLEGED EVENTS HAVE OCCASIONALLY RESULTED IN THE EXPLANT OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD GZB ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 118344

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention