MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-08-04 for PERICARDIAL PATCH - 5 CM X 12 CM 710 HP710 manufactured by Medtronic Heart Valves, Inc..
[20139030]
Healthcare professional reported that the pericardial patch was used on pt for a dura patch. One week later pt had an inflamatory reaction and developed signs of hydrocephalus. Recovered after 4 week treatment with steroids.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025587-2000-00060 |
| MDR Report Key | 288680 |
| Report Source | 05 |
| Date Received | 2000-08-04 |
| Date of Report | 2000-07-06 |
| Date of Event | 2000-04-12 |
| Date Facility Aware | 2000-04-12 |
| Report Date | 2000-07-06 |
| Date Reported to Mfgr | 2000-07-06 |
| Date Mfgr Received | 2000-07-06 |
| Device Manufacturer Date | 1999-11-01 |
| Date Added to Maude | 2000-08-09 |
| 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 | 3 |
| Manufacturer Contact | KATHRYN LYNESS |
| Manufacturer Street | 7000 CENTRAL AVENUE N.E. |
| Manufacturer City | MINNEAPOLIS MN 55440 |
| Manufacturer Country | US |
| Manufacturer Postal | 55440 |
| Manufacturer Phone | 7635142860 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERICARDIAL PATCH - 5 CM X 12 CM |
| Generic Name | BOVINE PERICARDIAL PATCH |
| Product Code | MFX |
| Date Received | 2000-08-04 |
| Model Number | 710 |
| Catalog Number | HP710 |
| Lot Number | S00846001I |
| ID Number | NA |
| Device Expiration Date | 2002-11-22 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 DAY |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 279362 |
| Manufacturer | MEDTRONIC HEART VALVES, INC. |
| Manufacturer Address | 1851 EAST DEERE AVE. SANTA ANA CA 92705 US |
| Baseline Brand Name | HANCOCK PERICARDIAL PATCH |
| Baseline Generic Name | PERICARDIAL PATCH |
| Baseline Model No | 710 |
| Baseline Catalog No | * |
| Baseline ID | * |
| Baseline Device Family | PATCHES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830883 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-08-04 |