BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION, DUAL 4 CHANNEL 30CM

    MDR report key: 2000748 · Received February 17, 2011

    Report

    Report Number
    1627487-2011-00212
    Event Type
    Injury
    Date Received
    February 17, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION DIV.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL RESULTS: AS RECEIVED, THE EXTENSION PASSED ALL FUNCTIONAL TESTS AND APPEARED IN GOOD CONDITION. 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 1 OF 2. REFERENCE MFR REPORT # 1627487-2011-00213. THE PT RECEIVED HIS SCS SYSTEM INCLUDING A PERCUTANEOUS LEAD AND LEAD EXTENSION. IT WAS REPORTED THAT PT SUFFERED MULTIPLE FALLS AND LOST STIMULATION AS A RESULT. EFFORTS TO RECAPTURE THERAPY VIA REPROGRAMMING YIELDED LIMITED SUCCESS. SURGICAL INTERVENTION WAS UNDERTAKEN ON (B)(6) 2011 TO REPLACE THE PT'S EXTENSION. UPON EXPLANT, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. STIMULATION WAS REGAINED AS A RESULT OF THE AFOREMENTIONED PROCEDURE; HOWEVER, INTRAOPERATIVE TESTING OF THE LEAD REVEALED INVALID IMPEDANCE MEASUREMENTS FOR SEVERAL CONTACTS. THE EXPLANTED EXTENSION WAS RETURNED TO THE MFR; HOWEVER, THE LEAD IN QUESTION REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTENSION, DUAL 4 CHANNEL 30CM SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION DIV. 3343 115802

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention