BEUDAMED
    FDA Adverse Event Other Summary report: N

    PTI OMNISTIM

    MDR report key: 691562 · Received March 3, 2006

    Report

    Report Number
    691562
    Event Type
    Other
    Date Received
    March 3, 2006
    Date of Event
    February 27, 2006
    Report Date
    March 3, 2006
    Manufacturer
    LOHMANN AND RAUSCHER, INC.
    Product Code
    IPF
    Report Source
    User Facility report
    Reporter Location
    OH, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS AT OUTPATIENT PHYSICAL THERAPY CENTER. ELECTRICAL STIMULATION UNIT WAS APPLIED TO PATIENT'S LEFT SHOULDER VIA 4 ELECTRODES IN A CROSS PATTERN FOR INTERFERENTIAL STIMULATION. UNIT WAS SET AT 5000 HZ ON FREQUENCY DIFFERENTIAL, RATE OF 65 AND INTENSITY WAS TURNED ON TO LESS THAN 1 ON THE OUTPUT WHEN PATIENT REPORTED FEELING A SHOCK. THE INTENSITY WAS IMMEDIATELY TURNED OFF, AT WHICH TIME THE PATIENT REPORTED FEELING ANOTHER SHOCK. THE UNIT WAS REMOVED ALONG WITH ALL ELECTRODES AND THE AREA WAS INSPECTED. NO VISIBLE MARKS WERE NOTED. THE PATIENT RELATED INCREASED SORENESS OVER LEFT ANTERIOR SHOULDER AREA. ICE WAS APPLIED AND THE PATIENT REPORTED THE PAIN WAS DECREASING OVER TIME. BIOMED WAS ALERTED AND INSPECTED THE UNIT. TESTING WAS COMPLETED AND NO PROBLEMS WERE NOTED. THE UNIT WAS SENT TO A THIRD PARTY SERVICE ORGANIZATION FOR FURTHER TESTING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PTI OMNISTIM STIMULATOR, THERAPEUTIC MUSCLE IPF LOHMANN AND RAUSCHER, INC. 3020 *

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR