BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY PLUS

    MDR report key: 6312552 · Received February 8, 2017

    Report

    Report Number
    3004209178-2017-02851
    Event Type
    Malfunction
    Date Received
    February 8, 2017
    Date of Event
    December 1, 2016
    Report Date
    February 8, 2017
    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
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED VIA A MANUFACTURER REPRESENTATIVE AND A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR BRACHIAL PLEXUS. IT WAS REPORTED THAT THERE WERE IMPEDANCE MEASUREMENTS TAKEN THAT WERE GREATER THAN 4,000 OHMS. THE IMPLANTABLE NEUROSTIMULATOR BATTERY WAS LOW. THE PATIENT IS RECEIVING THERAPY, BUT ONCE IN A WHILE EXPERIENCES A ZING OR JOLT. THE PATIENT WAS HAVING A REVISION DUE TO NORMAL BATTERY DEPLETION ON THE DAY OF THE REPORT. IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS AT NORMAL END OF LIFE, THE LEAD WAS CERVICAL, AND THE ZINGING HAD BEEN OCCURRING FOR SEVERAL MONTHS (2016). THE PATIENT ENDED UP HAVING THE BATTERY SWAPPED OUT, AND THE IMPEDANCES WERE NORMAL AFTER THE IMPLANTABLE NEUROSTIMULATOR WAS REPLACED, SO THE EXTENSION AND LEADS WERE NOT REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    94074 SYNERGY PLUS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7479

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR