BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE PERCUTANEOUS LEAD

    MDR report key: 2030959 · Received March 22, 2011

    Report

    Report Number
    1627487-2011-01289
    Event Type
    Injury
    Date Received
    March 22, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 21, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT WAS NOT ANALYZED AS THE COMPLAINT OF LEAD MIGRATION COULD NOT BE CONFIRMED VIA LABORATORY TESTING. 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

    DEVICE 2 OF 2. REFERENCE MFR REPORT: 1627487-2011-01288. THE PT REC'D HER SCS SYSTEM, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT FELL SHORTLY AFTER IMPLANT AND NEVER REGAINED EFFECTIVE STIMULATION COVERAGE. REPROGRAMMING EFFORTS WERE UNSUCCESSFUL AT RESOLVING THE ISSUE. THE PHYSICIAN EXPLANTED AND REPLACED THE LEADS WITH ONE SURGICAL LEAD ON (B)(6) 2011. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE PERCUTANEOUS LEAD SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3183 3111345

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Required Intervention