BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRIS COMPACT MRI

    MDR report key: 3850625 · Received June 5, 2014

    Report

    Report Number
    6000153-2014-00112
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 9, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE STYLET STICKS DURING INSERTION. THE REPORTER STATED THAT DURING A TRIAL PROCEDURE ON (B)(6) 2014 THEY WERE UNABLE TO USE TWO LEADS BECAUSE THE HEALTHCARE PROFESSIONAL (HCP) WAS UNABLE TO INSERT THE STYLET INTO EITHER LEAD AS THE STYLET WAS GETTING CAUGHT ON THE PROXIMAL ELECTRODES. IT WAS NOTED THAT A DIFFERENT TRIAL LEAD WAS USED AND THAT WORKED FINE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT ALL OF THE LEADS WERE TOSSED DURING SURGERY. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330000 VECTRIS COMPACT MRI STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 977A260

    Patients

    Seq Age Sex Outcome Treatment
    1