BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2033519 · Received March 24, 2011

    Report

    Report Number
    1627487-2011-01295
    Event Type
    Injury
    Date Received
    March 24, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 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
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION 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 ((B)(6)) REC'D HER SCS SYSTEM, INCLUDING AN EXTENSION, ON (B)(6) 2006. IT WAS REPORTED THAT THE PT LOST STIMULATION. DIAGNOSTIC TESTS EXHIBITED INVALID IMPEDANCE READINGS ON THE PT'S LEADS. IT WAS REPORTED THAT INTRAOPERATIVE TESTING ON (B)(6) 2011, REVEALED LOW OR NORMAL IMPEDANCE READINGS ON ALL LEAD CONTACTS. THE PHYSICIAN EXPLANTED AND REPLACED THE EXTENSION RESULTING IN NORMAL IMPEDANCE MEASUREMENTS. NO FURTHER PT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST JUDE MEDICAL - NEUROMODULATION DIVISION 3341 50535

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Required Intervention