BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 5075472 · Received September 14, 2015

    Report

    Report Number
    3004209178-2015-17919
    Event Type
    Malfunction
    Date Received
    September 14, 2015
    Report Date
    August 20, 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 MEDICAL PRODUCTS: PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 748910, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: EXTENSION; PRODUCT ID 3093-28, LOT# V000871, PRODUCT TYPE: LEAD; PRODUCT ID 3093-28, LOT# J0511542V, PRODUCT TYPE: LEAD. (B)(4). THE DEVICE WAS USED FOR AN OFF-LABEL INDICATION. THE THERAPY INDICATION THE DEVICE WAS USED FOR WAS EZW. THE DEVICE WAS USED FOR AN OFF-LABEL INDICATION. THE PMA ASSOCIATED WITH THE THERAPY INDICATION THE DEVICE WAS USED FOR WAS (B)(4).

    Description of Event or Problem · 1

    THE CONSUMER REPORTED THAT THEY HAD A C-SECTION IN 2014, AFTER WHICH THEIR IMPLANT HAD NOT BEEN WORKING. IT WAS NOTED THAT SYMPTOMS WERE REPORTED. THE PATIENT COULD STILL CONNECT TO THE DEVICE, HOWEVER. THE PATIENT'S INDICATION FOR USE OF THE STIMULATION SYSTEM WAS URINARY DYSFUNCTION/ SACRAL NERVE STIMULATION. NO DIAGNOSTICS/TROUBLESHOOTING, INTERVENTIONS OR OUTCOME WAS REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    605677 SYNERGY STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7427

    Patients

    Seq Age Sex Outcome Treatment
    1 00029 YR