BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE EXTENSION

    MDR report key: 2142162 · Received May 26, 2011

    Report

    Report Number
    1627487-2011-01568
    Event Type
    Malfunction
    Date Received
    May 26, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 26, 2011
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 1 OF 2. REFERENCE MANUFACTURER REPORT: 1627487-2011-01569. THE PT (B)(6) RECEIVED AN SCS TRIAL SYSTEM, INCLUDING AN EXTENSION, ON (B)(6) 2011. ON (B)(6) 2011, THE PHYSICIAN ATTEMPTED TO CONVERT THE TRIAL SYSTEM TO A PERMANENT SYSTEM. DURING THE PROCEDURE, THE PHYSICIAN REPORTED THAT HE COULD NOT DISCONNECT THE ELECTRODE FROM THE EXTENSION DURING EXPLANTATION WITHOUT UNDOING THE SCREW. HE REINSERTED THE ELECTRODE INTO THE EXTENSION AND TRIED TO TIGHTEN THE SCREW AGAIN. IT WAS REPORTED THAT THE TORQUE WRENCH WAS USED AND THE "CLICK" SOUND WAS AUDIBLE, BUT THE ELECTRODE COULD BE EASILY REMOVED FROM THE EXTENSION'S CONNECTOR BLOCK. THE SURGERY WAS TERMINATED BECAUSE OF THE ISSUE, AND THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE DEVICES. HOWEVER, A PROCEDURE DATE IS CURRENTLY UNDETERMINED. NO FURTHER INFO IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE EXTENSION SPINAL CORD STIMULATION EXTENSION LGW ST. JUDE MEDICAL - NEUROMODULATION 3383 3269070

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention