BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNERGY

    MDR report key: 2092144 · Received April 27, 2011

    Report

    Report Number
    6000032-2011-03124
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    January 1, 2010
    Report Date
    April 11, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO, MED REL
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS WITH ELECTRODES 0 AND 4. STIMULATION WAS FINE WITH ELECTRODES 1 AND 2 BUT WANTED TO USE ELECTRODES 0 AND 4 TO GET STIMULATION HIGHER IN BACK. THE PT EXPERIENCED INTERMITTENT STIMULATION. IT WAS NOTED THE PT FELL, WHICH WAS NOT TRAUMATIC, AND THE STIMULATION WAS NOT AFFECTED AT THAT TIME. IT WAS LATER REPORTED THAT THE PT EXPERIENCED NO STIMULATION FOLLOWING A FALL 1 YEAR AGO. THE DEVICE HAS BEEN TURNED OFF SINCE. THE IMPEDANCE MEASUREMENTS WERE GREATER THAN 4,000 OHMS ON ALL OF THE BIPOLAR PAIRS. ADD'L INFO HAS BEEN REQUESTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR LEAD: MODEL 3998, LOT# J0454411V| IMPLANTED:| EXPLANTED: