BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE LEAD KIT, 60CM LENGTH

    MDR report key: 2042039 · Received March 31, 2011

    Report

    Report Number
    1627487-2011-00453
    Event Type
    Injury
    Date Received
    March 31, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    ST JUDE MEDICAL - NEUROMODULATION DIVISION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS UNKNOWN FROM WHICH LOT THE IMPACTED LEAD GENERATED; THEREFORE, BOTH LOTS ARE BEING REPORTED. 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

    DEVICE 2 OF 3. REFERENCE MFR REPORT #S 1627487-2011-00450 AND 1627487-2011-00454. THE PT WAS IMPLANTED WITH AN SCS SYSTEM ON (B)(6) 2010, INCLUDING AN IPG AND TWO PERCUTANEOUS LEADS. IT WAS REPORTED THAT THE PT IS WITHOUT STIMULATION. IN ADDITION, THE RECHARGE INTERVALS AND RECHARGE DURATION FOR HIS IPG HAVE ALLEGEDLY INCREASED. A DIAGNOSTIC TEST REVEALED LOW IMPEDANCE MEASUREMENTS FOR ALL LEAD CONTACTS. AN X-RAY WAS TAKEN WHICH REVEALED A BEND IN ONE OF THE LEADS NEAR THE PROXIMAL END OF THE ANCHOR. SURGICAL INTERVENTION WILL BE UNDERTAKEN TO REPLACE THE PT'S LEADS; HOWEVER, A DATE FOR THE PROCEDURE HAS NOT BEEN SET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE LEAD KIT, 60CM LENGTH SPINAL CORD STIMULATION LEAD LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3186 2854856

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention