BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY VERSITREL

    MDR report key: 3951131 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13385
    Event Type
    Injury
    Date Received
    July 22, 2014
    Report Date
    June 30, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    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 EZW-URINARY DYSFUNCTION/SACRAL NERVE STIM. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 7435, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3889-33, LOT# V388976 SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: LEAD. PRODUCT ID: 748910, SERIAL # (B)(4) IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 748910, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3889-28, LOT# V462946 IMPLANTED: (B)(6) 2010, PRODUCT TYPE; LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT HAD A URINARY TRACT INFECTION (UTI).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427980 SYNERGY VERSITREL STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427V-NP

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Required Intervention