BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    MDR report key: 3806123 · Received May 12, 2014

    Report

    Report Number
    3007566237-2014-01302
    Event Type
    Injury
    Date Received
    May 12, 2014
    Date of Event
    March 1, 2014
    Report Date
    April 23, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE THERAPY THE DEVICE WAS USED FOR WAS GZF. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3389-28, SERIAL# UNKNOWN, PRODUCT TYPE LEAD PRODUCT ID 7489-51, SERIAL# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED AN ALLERGY TEST WAS PERFORMED. IT WAS FURTHER STATED THE PATIENT¿S ALLERGY TEST REVEALED THE PATIENT HAD POSITIVE (ALLERGIC) REACTIONS TO BENZOYLPEROXID, 1 ,4-BUTANDIODIGLYCIDYLETHER, AND P-TERT-BUTYLCATECHIN. IT WAS NOTED THE MANUFACTURER REPRESENTATIVE WAS IN THE PROCESS OF DETERMINING WHETHER THESE SUBSTANCES WERE PRESENT IN THE SYSTEM AT THE TIME OF FOLLOW-UP. IT WAS REPORTED THE PATIENT¿S EXPLANTED SYSTEM WOULD NOT BE RETURNED FOR ANALYSIS. IT WAS NOTED THE PATIENT WOULD RECEIVE A NEW SYSTEM IN THE FUTURE IF IT WAS POSSIBLE TO ATTAIN A CUSTOM SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT ¿SHOWED ALLERGIC REACTION¿ TO THEIR IMPLANTABLE NEUROSTIMULATOR (INS) SYSTEM AND THE ¿WHOLE SYSTEM WAS E XPLANTED¿ AS A RESULT. IT WAS NOTED THE PATIENT WAS ALIVE WITH NO INJURY AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283521 UNKNOWN IMPLANTABLE NEUROSTIMULATOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention