InjuryDRN
ENHANCE EXTERNAL COUNTER PULSATION
Received Apr 19, 2005 · Event occurred Oct 20, 2004
Report 2435300-2005-00003 · MDR key 592771
Device
Generic name
Device, Counterpulsating, External
Manufacturer
Vasomedical, Inc.Model number
TS3Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
81 YR
- Chest Pain
- Breathing difficulties
- Therapy/non-surgical treatment, aborted/stopped
- Treatment with medication(s)
- Hospitalization required
Narrative
Description of Event or Problem
DURING THE FIRST FIVE MINUTES OF THERAPY, PT BEGAN TO COMPLAIN OF SHORTNESS OF BREATH AND CHEST PAIN. PRESSURE OF SYSTEM WAS STILL LOW AT TIME OF EVENT. PT WAS ANXIOUS ABOUT THE THERAPY. COVERING PHYSICIAN WAS NOT FAMILIAR WITH THE THERAPY SO AMBULANCE WAS CALLED. NITRO WAS ADMINISTERED IN AMBULANCE AND CHEST PAIN WAS RESOLVED BEFORE GETTING TO ER. PT WAS ADMITTED WITH CHEST PAIN OVERNIGHT FOR OBSERVATION AND DISCHARGED FOLLOWING DAY. NO PROCEDURES WERE PERFORMED, NO FURTHER ACTION WAS TAKEN.