BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VECTRIS

    MDR report key: 3803292 · Received May 9, 2014

    Report

    Report Number
    6000153-2014-00088
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Date of Event
    April 17, 2014
    Report Date
    April 17, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    GZB
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE LEAD FOUND THE STYLET COIL OF THE LEAD BODY HAD FOREIGN MATERIAL BLOCKING STYLET INSERTION. IT WAS NOTED ANALYSIS OF THE STYLET (S/N UNKNOWN) FOUND NOT SIGNIFICANT ANOMALY. IT WAS NOTED THE STYLET WIRE WAS BENT. ANALYSIS OF THE STYLET (S/N UNKNOWN) FOUND NOT SIGNIFICANT ANOMALY. IT WAS NOTED THE STYLET WIRE WAS BENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE TRIAL IMPLANT PROCEDURE, THE HCP EXPERIENCED DIFFICULTY INSERTING THE LEAD. WHEN THE LEAD APPROACHED THE TARGET SITE, THERE WERE DIFFICULTIES DUE TO ¿SEVERE ADHESION¿ IN THE EPIDURAL SPACE. IT WAS ALSO NOTED THAT WHEN ADVANCING THE LEAD WHILE REPLACING THE STYLET AND APPLYING TORQUE, THE STYLET REPLACEMENT ¿BECAME HARDER¿ AND COULD NOT BE FULLY INSERTED. THE ELECTRODES WERE REPLACED WITH NEW ONE AND THE LEAD WAS INSERTED SUCCESSFULLY. IT WAS ALSO STATED THAT WHEN THE EXCESSIVE TORQUE IS APPLIED, ¿THE MAIN UNIT OF THE ELECTRODES IS DISTORTED¿ AND RESULTS IN A NARROWED SPACE FOR STYLET INSERTION. IT WAS REPORTED THERE WAS NO HEALTH HAZARD TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280953 VECTRIS STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF) GZB NEURO - VILLALBA 977A260

    Patients

    Seq Age Sex Outcome Treatment
    1