BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DUAL EXTENSION

    MDR report key: 2023234 · Received February 15, 2011

    Report

    Report Number
    1627487-2011-01249
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 14, 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
    NY, 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

    DEVICE 3 OF 4. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01247, 1627487-2011-01248 AND 1627487-2011-01250. THE PT HAS TWO SCS SYSTEMS. ONE SYSTEM WAS IMPLANTED ON (B)(6) 2009 AND INCLUDES AN IPG, FOUR PERCUTANEOUS LEADS, AND TWO EXTENSIONS (FROM TWO SEPARATE LOTS). THE SECOND SYSTEM WAS IMPLANTED ON (B)(6) 2010 AND INCLUDES AN IPG, FOUR PERCUTANEOUS LEADS, AND TWO EXTENSIONS (FROM TWO SEPARATE LOTS). IT WAS REPORTED THAT THE PT LOST STIMULATION. ONE LEAD EXHIBITED INVALID IMPEDANCE READINGS. ON (B)(6) 2011, THE PHYSICIAN EXPLANTED AND REPLACED ONE OF THE PT'S EXTENSIONS. THE EXPLANTED PRODUCT HAS NOT BEEN RETURNED TO THE MANUFACTURER. FOLLOW UP ON THE PT FOUND NO FURTHER ISSUES 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 3343 3108763

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention