BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OCTRODE 3/4 PERCUTANEOUS LEADS

    MDR report key: 1870820 · Received October 6, 2010

    Report

    Report Number
    1627487-2010-02773
    Event Type
    Injury
    Date Received
    October 6, 2010
    Date of Event
    September 8, 2010
    Report Date
    September 8, 2010
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS, INC.
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT LOT NUMBER OF THE DEVICE IS UNK. BOTH POSSIBLE LOT NUMBERS HAVE BEEN EVALUATED. DEVICE EVALUATION 2 OF 2. PLEASE SEE MFG REPORT #1627487-2010-02739 FOR EVALUATION OF DEVICE 1. EVALUATION: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS 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. ANS DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    DEVICE 2 OF 2. PLEASE SEE MFG REPORT #1627487-2010-02739 FOR DEVICE 1. ON (B)(6) 2008, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. ON (B)(6) 2010, THE PT WAS TALKING TO HIS DAUGHTER AND HE FELT A POP IN HIS NECK. THE PT HAS FALLEN 3 TIMES THIS SUMMER PRIOR TO (B)(6) 2010. THE LAST FALL HE HAD, HE HIT HIS HEAD (WHICH IS WHERE THE LEADS ARE PLACED). THE PT DID NOT HAVE THE EXACT DATES. THE MOST RECENT FALL WAS ABOUT TWO WEEKS AGO. AFTER FEELING THE POP IN HIS NECK, THE PT STARTED GETTING HIS HEADACHES BACK. AN X-RAY WAS TAKEN AND IT SHOWED THE LEAD HAD MIGRATED. ON (B)(6) 2010, THE PT HAD A LEAD REVISION. DURING THE REVISION, A TRIAL CABLE AND MTS WERE USED TO TEST THE LEAD. CONTACT #1 EXHIBITED INVALID LEAD IMPEDANCE SO THE DOCTOR DECIDED TO REPLACE THE LEAD. THE STRAIN RELIEF THAT HAD BEEN PLACED AT THE ANCHOR SITE WAS NO LONGER INTACT ALTHOUGH STRAIN RELIEFS WERE STILL PRESENT AT THE IPG AND EXTENSION SITES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OCTRODE 3/4 PERCUTANEOUS LEADS SPINAL CORD STIMULATION LEAD LGW ADVANCED NEUROMODULATION SYSTEMS, INC. 3181 85441

    Patients

    Seq Age Sex Outcome Treatment
    1 Other