MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2003-09-03 for ENHANCED EXTERNAL COUNTERPULSATION TS3 * manufactured by Vasomedical, Inc..
[318442]
When patient started course of therapy (their 3rd course) they complained of leg cramps in the right leg. Could not tolerate full treatment pressure or complete a session with out breaking to relieve pain. Four consecutive days passed until patient returned for treatment, due to a vacation. After the next treatment, patient was reported to have been admitted to the hospital for an occlusive thrombus in the right leg.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2435300-2003-00010 |
| MDR Report Key | 482246 |
| Report Source | 07 |
| Date Received | 2003-09-03 |
| Date of Report | 2003-09-02 |
| Date of Event | 2003-08-12 |
| Date Mfgr Received | 2003-08-13 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2003-09-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | THOMAS VARRICCHIONE |
| Manufacturer Street | 180 LINDEN AVE. |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 5169974600 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENHANCED EXTERNAL COUNTERPULSATION |
| Generic Name | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Product Code | DRN |
| Date Received | 2003-09-03 |
| Model Number | TS3 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 471132 |
| Manufacturer | VASOMEDICAL, INC. |
| Manufacturer Address | 180 LINDEN AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | EECP THERAPY SYSTEM |
| Baseline Generic Name | EECP |
| Baseline Model No | TS3 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | DEVICE, COUNTER-PULSATING, EXTERNAL |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K003469 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-09-03 |