BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 1230637 · Received November 6, 2008

    Report

    Report Number
    3004209178-2008-07275
    Event Type
    Malfunction
    Date Received
    November 6, 2008
    Date of Event
    October 1, 2008
    Report Date
    October 13, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD NO STIMULATION SENSATION AND WAS "IN A LOT OF PAIN" DESPITE ALL THREE GREEN LIGHTS COMING ON WHEN THE STIMULATOR WAS TURNED ON. THE PT WAS ALSO UNABLE TO ADJUST STIMULATION, RECEIVING TRIPLE BEEPS WHEN INCREASING AND DECREASING STIMULATION. THE PT'S STIMULATOR WAS INTERROGATED AND A POWER-ON-RESET CONDITION WAS NOTED. IT WAS ALSO NOTED THAT THE DEVICE WAS NEAR END OF LIFE. THE BATTERY DEPLETION WAS CONSIDERED STANDARD END OF LIFE. THE PT'S STIMULATOR WAS REPLACED. THE EXPLANTED STIMULATOR WAS NOT RETURNED TO THE MFR. NO PT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNERGY LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 7427 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention EXTENSION: MODEL 7465LZ, LOT # NKH009053V,| EXPLANTED:| EXTENSION: MODEL 7495LZ, LOT # NHK009052V,| EXPLANTED:| PROGRAMMER: MODEL 7435, LOT # NFT018209P| IMPLANTED:| IMPLANTED: