MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-10-12 for ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM ADS-1001 manufactured by Cardiomems, Inc..
| Report Number | 3004936110-2006-00004 |
| MDR Report Key | 841560 |
| Date Received | 2006-10-12 |
| Date of Report | 2006-09-25 |
| Date of Event | 2006-09-20 |
| Date Mfgr Received | 2006-09-20 |
| Device Manufacturer Date | 2006-07-01 |
| Date Added to Maude | 2007-04-28 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 75 FIFTH ST., NW STE. 440 |
| Manufacturer City | ATLANTA GA 30308 |
| Manufacturer Country | US |
| Manufacturer Postal | 30308 |
| Manufacturer Phone | 4049206700 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOSURE AAA PRESSURE SENSOR/DELIVERY SYSTEM |
| Generic Name | INTRASAC PRESSURE SENSOR/DELIVERY SYSTEM |
| Product Code | NQH |
| Date Received | 2006-10-12 |
| Model Number | NA |
| Catalog Number | ADS-1001 |
| Lot Number | OML60703-03 |
| ID Number | NA |
| Device Expiration Date | 2008-07-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 828821 |
| Manufacturer | CARDIOMEMS, INC. |
| Manufacturer Address | * ATLANTA GA * US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-12 |