BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SINGLE 8 EXTENSION, 60CM LENGTH

    MDR report key: 1790872 · Received August 6, 2010

    Report

    Report Number
    1627487-2010-01328
    Event Type
    Malfunction
    Date Received
    August 6, 2010
    Date of Event
    October 30, 2008
    Report Date
    October 31, 2008
    Manufacturer
    ADVANCED NEUROMODULATION SYSTEMS
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS : THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. THE EXTENSION WAS RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. A TEST LEAD WAS USED AND THE TERMINAL END ELECTRODES WOULD EXTEND BEYOND THE BLOCK CONNECTOR. IT IS POSSIBLE THE BLOCK CONNECTOR FOR A DIFFERENT DEVICE WAS USED INSTEAD OF ONE FOR A LEAD EXTENSION. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). 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 1 OF 2. REFERENCE MFR REPORT # 1627487-2010-01334. THE PT WAS IMPLANTED WITH A TRIAL SYSTEM CONSISTING OF A PADDLE LEAD AND TWO EXTERNALIZED EXTENSIONS ON (B)(6) 2008. IT WAS REPORTED THAT WHEN STIMULATION WAS TURNED ON THE FOLLOWING DAY, ONE SIDE WOULD NOT PRODUCE STIMULATION. A NEW TRIAL CABLE AND MTS WERE TRIED WITH NO SUCCESS. A FLUOROSCOPY SHOWED THAT ONE OF THE LEAD'S TAILS WAS OVER-INSERTED INTO THE EXTENSION'S HEADER. DURING AN ADDITIONAL PROCEDURE, THE PHYSICIAN RECONNECTED THE LEAD TO THE EXTENSION AND THE PT RECEIVED GOOD STIMULATION. FOLLOWING THE TRIAL PERIOD, THE EXTENSION WAS REMOVED AND RETURNED TO ANS FOR EVAL. IT WAS NOT NOTED FROM WHICH LOT THE RETURNED EXTENSION CAME FROM, SO BOTH ARE BEING REPORTED. NO FURTHER INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SINGLE 8 EXTENSION, 60CM LENGTH SPINAL CORD STIMULATION EXTENSION LGW ADVANCED NEUROMODULATION SYSTEMS 3386 R172212

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention