BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4125906 · Received September 29, 2014

    Report

    Report Number
    3007566237-2014-02733
    Event Type
    Injury
    Date Received
    September 29, 2014
    Report Date
    September 2, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS USED FOR AN OFF-LABEL INDICATION. THE INDICATION THE DEVICE WAS USED FOR WAS EZW. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 309328, LOT# UNKNOWN, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE LEAD WAS TO BE REPLACED ON (B)(6) 2015.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿OPEN¿ CIRCUITS WERE MEASURED ON THE LEAD. A LOSS OF STIMULATION AND LESS THAN 50% THERAPY RELIEF WAS NOTED. THE LEAD WAS TO BE REPLACED, THOUGH THE DATE WAS NOT YET CONFIRMED. A FOLLOW UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    604613 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC NEUROMODULATION 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention