BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURESCAN

    MDR report key: 4162081 · Received October 10, 2014

    Report

    Report Number
    6000153-2014-00176
    Event Type
    Malfunction
    Date Received
    October 10, 2014
    Date of Event
    September 18, 2014
    Report Date
    September 18, 2014
    Manufacturer
    NEURO - VILLALBA
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID: NEU_INS_STIMULATOR, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: NEU_PTM_PROG, LOT# SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PLASTIC COVER WAS LIFTED OFF OF A LEAD KIT, THE LEAD WAS ¿LIKE A SNAKE¿ AND IT FLEW RIGHT OFF THE STAND. THIS OCCURRED WHILE IN A CASE WITH A COMPETITIVE DOCTOR. THE LEAD WAS NOT IMPLANTED IN A PATIENT, SO THERE WAS NO PATIENT INVOLVEMENT. USUALLY THE LEADS ARE SECURED WITH PLASTIC GROMETS BUT THIS KIT WAS NOT LOOKED AT. THE LEAD SPRUNG OUT OF THE STERILE FIELD SO IT WAS NOT USED. IT WAS NOTED THAT THE OUTSIDE OF THE PACKAGE LOOKED NORMAL AND THE HEALTHCARE PROVIDER (HCP) WHO OPENED THE PACKAGE KNEW HOW TO OPEN THE LEAD PACKAGE. AN IMPLANT LEAD WAS USED INSTEAD OF THE TRIAL LEAD. THE LEAD WAS FROM THE MANUFACTURER REPRESENTATIVE¿S TRUNK STOCK. FOLLOW-UP WAS CONDUCTED TO DETERMINE IF A PATIENT WAS ASSOCIATED WITH THE EVENT AND IF THE DEVICE WAS GOING TO BE RETURNED. THIS EVENT WILL BE UPDATED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS A TRIAL PATIENT. THE MANUFACTURING REPRESENTATIVE WAS NOT PLANNING ON RETURNING THE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644725 SURESCAN STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW NEURO - VILLALBA 977D260

    Patients

    Seq Age Sex Outcome Treatment
    1 00064 YR