MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2008-08-01 for EDWARDS PERICARDIAL PATCH 4700 NA manufactured by Edwards Lifesciences.
[915294]
It was reported that the patient expired in 2008, after an implant duration of. 02 mos, due to unknown reasons. It is unknown if the death was device related. No further details were provided. It was additionally reported that a second device, model #6900ptfx, was implanted. Refer to mfr #6000002-2008-08305. A third device was also explanted, model #6900ptx. Refer to mfr #6000002-2008-07886.
Patient Sequence No: 1, Text Type: D, B5
[8111037]
Device not returned.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 6000002-2008-08302 |
| MDR Report Key | 1085759 |
| Report Source | 05,06,07 |
| Date Received | 2008-08-01 |
| Date of Report | 2008-07-22 |
| Date of Event | 2008-07-22 |
| Date Facility Aware | 2008-07-22 |
| Date Mfgr Received | 2008-07-22 |
| Date Added to Maude | 2008-08-06 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | NEIL LANDRY |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal | 92614 |
| Manufacturer Phone | 9492502289 |
| Manufacturer G1 | EDWARDS LIFESCIENCES |
| Manufacturer Street | ONE EDWARDS WAY |
| Manufacturer City | IRVINE CA 92614 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 92614 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EDWARDS PERICARDIAL PATCH |
| Generic Name | PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2008-08-01 |
| Model Number | 4700 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1066085 |
| Manufacturer | EDWARDS LIFESCIENCES |
| Manufacturer Address | IRVINE CA 92614 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2008-08-01 |