InjuryDRN
ENHANCE EXTERNAL COUNTERPULSATING
Received Aug 18, 2005 · Event occurred Aug 10, 2005
Report 2435300-2005-00004 · MDR key 629103
Device
Generic name
Device, External, Counter-pulsating
Manufacturer
Vasomedical, Inc.Model number
TS3Catalog number
*
Lot number
*
Product problems
- Unknown (for use when the device problem is not known)
Patient
73 YR
- Pain
- Numbness
- Therapy/non-surgical treatment, aborted/stopped
- Hospitalization required
Narrative
Description of Event or Problem
FIRST THERAPY SESSION STOPPED 2X DUE TO PT C/O LEFT LEG NUMBNESS AND PAIN. FOOT APPEARED MOTTLED AND COOL. PHYSICIAN ORDERED DOPPLER - ABSENT LEFT DP/PT PULSES AND FOOT NOT IMPROVING DESPITE ATTEMPTS BY PT TO IMPROVE CIRCULATION. PT ADMITTED.