BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNERGY

    MDR report key: 1111558 · Received August 13, 2008

    Report

    Report Number
    6000032-2008-04929
    Event Type
    Injury
    Date Received
    August 13, 2008
    Date of Event
    July 14, 2008
    Report Date
    July 14, 2008
    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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT EXPERIENCED NO STIMULATION SENSATION FOLLOWING A FALL. HE WENT WITHOUT STIMULATION THERAPY FOR APPROX 6 MONTHS AND WAS THEN SEEN IN A CLINIC. IMPEDANCES WERE GREATER THAN 4000 OHMS ON ALL OR SOME OF THE BIPOLAR PAIRS. THE IMPEDANCE TEST WAS RERUN AT AN AMPLITUDE OF 3 VOLTS AND A FREQUENCY OF 450 MILLISECONDS. MANY BIPOLAR PAIR IMPEDANCES WERE 3006 OHMS. IMPEDANCE MEASUREMENTS OF BIPOLAR PAIRS 0-1, 1-4 AND 1-2 WERE 1496 OHMS. REPROGRAMMING DID NOT CORRECT THE LACK OF STIMULATION SENSATION. THE HCP ORDERED X-RAYS. THE PT WAS REPORTED TO HAVE RECOVERED WITHOUT SEQUELA. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    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 Required Intervention IMPLANTED| LEAD MODEL 3888| EXPLANTED| EXTENSION MODEL 7495-25| EXPLANTED| EXTENSION MODEL 7495-25| IMPLANTED| EXPLANTED| LEAD MODEL 3888| EXPLANTED