EECP DEVICE MANUFACTURED BY VASOMEDICAL, INC. UNK *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-12-13 for EECP DEVICE MANUFACTURED BY VASOMEDICAL, INC. UNK * manufactured by Vasomedical, Inc..

Event Text Entries

[307317] The patient experienced subacute thrombosis of femoral arterial tree following treatment with enhanced external counterpulsation. Pt was receiving treatment with eecp for several months at the time of the event. Prior to the event they had received a total of 47 eecp treatments for angina pectoris and mild congestive heart failure. Following the 47th treatment, pt experienced the acute onset of lower hip pain that extended to the popliteal fossa. The paint was persistent and progressive and eventually extended down to the calf. It was later accompanied by foot numbness, at which occasion, pt presented to the er. A vascular examination at that time determined that there was no evidence of limb-threatening ischemia and the patient was referred for neurological examination as an outpatient. An emg test disclosed evidence of polyneuropathy that was felt to be due to a combination of diabetes and possible limb ischemia. Approximately 6 weeks after the final eecp treatment and onset of symptoms, pt's left foot became acutely edematous and again presented to the er. On this occasion, pt was diagnosed with limb-threatening ischemia of the left leg. Mra showed three severe stenoses of the femoral arterial tree below the mid-thigh according to the patient and pt was eventually treated with ptca of 2 of these lesions that were accessible. Currently, 4 days after surgery, the symptoms of numbness and swelling persist.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1026999
MDR Report Key433597
Date Received2002-12-13
Date of Report2002-12-13
Date of Event2002-10-15
Date Added to Maude2002-12-23
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameEECP DEVICE MANUFACTURED BY VASOMEDICAL, INC.
Generic NameEECP
Product CodeDRN
Date Received2002-12-13
Model NumberUNK
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key422540
ManufacturerVASOMEDICAL, INC.
Manufacturer Address180 LINDEN AVENUE WESTBURY NY 11590 US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention; 4. Deathisabilit 2002-12-13

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