MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02,05 report with the FDA on 2006-08-09 for LEAD NEURO LEADN NA manufactured by Neurological Division, Medtronic, Inc..
[500267]
Clinical study reports patient with left side weakness in leg and hand resulting in prolonged hospitalization. Hcp reports the patient had stage one surgery performed in 2006. Immediately following surgery the patient had left side weakness in the leg and hand. Ct scan of the brain was performed and showed no evidence of acute stroke or hemorrhage. The patient will remain in the hospital for rehabilitation and physical therapy. The neurologist believes the patient suffered from a small stroke related to the surgery. There was no report of device explantation. A follow up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2006-01316 |
| MDR Report Key | 748951 |
| Report Source | 02,05 |
| Date Received | 2006-08-09 |
| Date of Report | 2006-07-21 |
| Date of Event | 2006-07-17 |
| Date Facility Aware | 2006-07-21 |
| Date Mfgr Received | 2006-07-21 |
| Date Added to Maude | 2006-08-16 |
| 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 | 3 |
| Manufacturer Contact | NIKOLE RAHN |
| Manufacturer Street | 710 MEDTRONIC PARKWAY LN145 |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635051077 |
| Manufacturer G1 | MEDTRONIC, INC. |
| Manufacturer Street | 800 53RD AVENUE NE |
| Manufacturer City | MINNEAPOLIS MN 55421 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55421 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEAD NEURO |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2006-08-09 |
| Model Number | LEADN |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 736732 |
| Manufacturer | NEUROLOGICAL DIVISION, MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVENUE NE MINNEAPOLIS MN 55421 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-08-09 |