BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VENODYNO

    MDR report key: 203347 · Received December 21, 1998

    Report

    Report Number
    MW1015269
    Event Type
    Injury
    Date Received
    December 21, 1998
    Date of Event
    July 15, 1997
    Report Date
    December 18, 1998
    Manufacturer
    ADVANCED INSTRUMENTS, INC.
    Product Code
    JOW
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 71 YEAR OLD MALE CONSENTED TO PARTICIPATE IN A TRIAL COMPARING LOW MOLECULAR WEIGHT HEPARIN, EXTERNAL PNEUMATIC COMPRESSION, AND THE COMBINATION OF LOW MOLECULAR WEIGHT HEPARIN AND EXTERNAL PNEUMATIC COMPRESSION IN THE PREVENTION OF DEEP VEIN THROMBOSIS FOLLOWING TOTAL KNEE REPLACEMENT. PT WAS RANDOMIZED TO RECEIVE THE COMBINATION OF LOW MOLECULAR WEIGHT HEPARIN AND PNEUMATIC COMPRESSION. PT CAME TO THE HOSP FOR A RIGHT TOTAL KNEE REPLACEMENT WHICH WAS DONE ON 07/14/97. ON 07/15/97 AT APPROX 17:00, PT WAS FOUND TO HAVE A CHANGE IN MENTAL STATUS AND LEFT SIDE WEAKNESS. THE PT SUBSEQUENTLY DEVELOPED A LEFT-SIDED HEMIPARESIS WITH LEFT-SIDED FACIAL DROPPING. THE PT WAS FOUND TO HAVE A RIGHT-SIDED PARIETAL TEMPORAL INFARCTION. AT THAT TIME, THE PT WAS ON A MORPHINE PUMP WHICH WAS DISCONTINUED. THE LOVENOX INJECTIONS AND EXTERNAL PNEUMATIC COMPRESSION WERE ALSO DISCONTINUED. THE SYMPTOMS IMPROVED SOMEWHAT AFTER NARCAN INJECTION. THE PT WAS TRANSFERRED TO INTENSIVE CARE UNIT THEN NEUROLOGY AND STABILIZED. THE PT WAS STARTED ON HEPARIN AND LATER COUMADIN WHICH WERE ADJUSTED AS PER PROTHROMBIN TIME/PARTIAL THROMBOPLASTIN TIME. PNEUMATIC COMPRESSION, EXTERNAL: 7/14/98 AT 16:30, TO 7/15/97 AT 17:00.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VENODYNO VENOUS COMPRESSION SYSTEM FOR DVT PROPHYLAXIS WITH COMPRESSI JOW ADVANCED INSTRUMENTS, INC. 510 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Life Threatening| R LOVENOX 30MG/9.3ML.