BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 4853500 · Received June 18, 2015

    Report

    Report Number
    3004209178-2015-11828
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    May 28, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 399930, LOT# J0519180V, IMPLANTED: 2005-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE LEAD. PRODUCT ID 748925, SERIAL# (B)(4), IMPLANTED: 2005-(B)(6), EXPLANTED: 2015-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 7435, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD AN EXPLANT OF THE DEVICE. THE MANUFACTURER REPRESENTATIVE (REP) WAS NOTIFIED OF THE EXPLANT AFTER THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE PATIENT WAS HAVING A T10-L3 FUSION CONCURRENTLY. THE HEALTHCARE PROVIDER (HCP) NOTED THAT THE PATIENT REPORTED ¿IT DOESN¿T WORK¿, THE REP HAD NOT SPOKEN WITH THE PATIENT. NO OTHER DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS PERFORMED. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. PATIENT STATUS AT THE TIME OF THE REPORT WAS ALIVE, NO INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396828 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention