BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANCHOR

    MDR report key: 2993949 · Received March 1, 2013

    Report

    Report Number
    1627487-2013-13234
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    GZB
    PMA / PMN Number
    K092371
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 6 OF 6. REFERENCE MFR. REPORTS: 1627487-2013-13229, 1627487-2013-13230, 1627487-2013-13231, 1627487-2013-13232, AND 1627487-2013-13233. THE PT HAS 2 LEADS FROM EACH MODEL NUMBER, 2 EXTENSIONS, AND 2 ANCHORS FROM DIFFERENT LOT NUMBERS, SUBMITTING REPORTS FOR ALL. IT WAS REPORTED THE PT UNDERWENT A PERMANENT IMPLANT PROCEDURE. THE PT HAS PROSTHESIS IN HIS RIGHT EYE, HOWEVER, WHEN HE WOKE UP IN RECOVERY, HE WAS NOT ABLE TO SEE FROM HIS LEFT EYE. THE PT WAS IMPLANTED WITH FOUR LEADS, 2 PLACED SUBCUTANEOUSLY (OFF-LABEL) AT L5-S1 ON BOTH SIDES AND 2 PLACED MIDLINE AND TO THE LEFT AT T8. DURING INTER-OPERATIVE TESTING, THE PT DID NOT REPORT ANY VISION PROBLEM. A CT SCAN WAS INCONCLUSIVE AND THE ENTIRE SCS SYS WAS EXPLANTED. A MRI OF THE BRAIN AND SUBSEQUENT TESTS WERE ALSO INCONCLUSIVE. ON (B)(6) 2013, THE PT'S PHYSICIAN REPORTED THE PT WAS ABLE TO SEE SHADES AND THE OUTLINE OF HIS HAND WHEN HELD IN FRONT OF HIS FACE. FOLLOW-UP INFO IDENTIFIED THE PT HAD UNDERGONE MULTIPLE TESTS AND SCANS AND NOTHING WAS FOUND, THE PT IS STILL UNABLE TO SEE. ADD'L FOLLOW-UP PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89085 ANCHOR SCS ANCHOR GZB ST. JUDE MEDICAL - NEUROMODULATION 1192 3410980

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention