BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2153456 · Received June 21, 2011

    Report

    Report Number
    3004209178-2011-04621
    Event Type
    Malfunction
    Date Received
    June 21, 2011
    Date of Event
    January 1, 2011
    Report Date
    May 24, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT IN THE RIGHT LEG. THE PATIENT HAD REACHED THE MAXIMUM SETTINGS. IT WAS LATER REPORTED THAT IMPEDANCE READINGS WERE GREATER THAN 4,000 OHMS ON ALL OF THE BIPOLAR PAIRS. THE PATIENT HAD STIMULATION ON THE LEFT SIDE BUT NOT ON THE RIGHT SIDE. THE IMPEDANCE READINGS ON THE RIGHT SIDE, WITH ELECTRODES 4-7 WERE: 4/5 = 1395; 4/6 = 1395; 4/7 = 4000; 5/6 = 1395; 5/7 = 4000; 6/7 = 4000. THE PATIENT ALSO EXPERIENCED A SHOCKING OR JOLTING SENSATION WHEN THE SETTINGS WERE INCREASED DURING REPROGRAMMING. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 7435, LOT# NFT005431P| EXTENSION: MODEL 7495-10, LOT# NAH004597N| LEAD: MODEL 3998, LOT# L79022| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-10, LOT# NAH004513N