BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LEAD 3876-45 OCTAD 1X8 SC

    MDR report key: 2992610 · Received March 7, 2013

    Report

    Report Number
    3007566237-2013-00712
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 20, 2013
    Report Date
    February 20, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_STYLET_ACC, PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STYLET WOULD NOT ADVANCE TO THE END OF THE LEAD. IT BECAME DAMAGED WHILE TRYING TO INSERT INTO THE STYLET. THE SURGEON WAS IMPLANTING THE LEAD BUT HE NEEDED TO SWAP THE STYLET OUT FOR A STRAIGHT ONE. UPON RE-INSERTING THE STIFF-BENT STYLET, IT WOULD NOT ADVANCE AND BECAME DAMAGED. ANOTHER LEAD WAS USED SUCCESSFULLY. THE CASE WAS COMPLETED ON THE TABLE WITH NO FURTHER ISSUES. THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT AND NO FURTHER ACTION WAS NECESSARY. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96902 LEAD 3876-45 OCTAD 1X8 SC STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 3876-45 0205273178

    Patients

    Seq Age Sex Outcome Treatment
    1 00067 YR