ENHANCED EXTERNAL COUNTERPULSATION TS3 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-12-05 for ENHANCED EXTERNAL COUNTERPULSATION TS3 * manufactured by Vasomedical, Inc..

Event Text Entries

[295840] Thirty-four minutes into the first treatment session, pt felt initial symptoms of a seizure and notified therapist. Seizure symptoms worsened, 1mg valium administered orally without effect, second dose administered, symptoms dissipated. Doctor called in to room. Pt seemed to recover from seizure like symptoms and complained of chest pain. Additional seizure like symptoms returned. Pt was taken to er where the symptoms dissipated on their own. Left heart catheterization and ptca was performed. Pt was discharged four days later.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2435300-2003-00014
MDR Report Key500231
Report Source07
Date Received2003-12-05
Date of Report2003-12-05
Date of Event2003-11-17
Date Mfgr Received2003-11-18
Device Manufacturer Date2001-11-01
Date Added to Maude2003-12-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location0
Manufacturer ContactTHOMAS VARRICCHIONE
Manufacturer Street180 LINDEN AVE.
Manufacturer CityWESTBURY NY 11590
Manufacturer CountryUS
Manufacturer Postal11590
Manufacturer Phone5169974600
Manufacturer G1*
Manufacturer Street*
Manufacturer City*
Manufacturer Country*
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameENHANCED EXTERNAL COUNTERPULSATION
Generic NameDEVICE, COUNTER-PULSATING, EXTERNAL
Product CodeDRN
Date Received2003-12-05
Model NumberTS3
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrN
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key488998
ManufacturerVASOMEDICAL, INC.
Manufacturer Address180 LINDEN AVE. WESTBURY NY 11590 US
Baseline Brand NameEECP THERAPY SYSTEM
Baseline Generic NameEECP
Baseline Model NoTS3
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilyDEVICE, COUNTER-PULSATING, EXTERNAL
Baseline Shelf Life [Months]NA
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK003469
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization 2003-12-05

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