MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03,05 report with the FDA on 2006-06-05 for UNK LEAD NA manufactured by Medtronic, Inc, Neurological Div.
[16407841]
Literature report of one patient who developed a minor and asymptomatic hemorrahge which resolved within one week. Upon follow up with the hcp, it was reported the hemorrhage was located at the level of the amygdalar electrode. No patient treatment was required or performed. The patient recovered without sequela.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2006-00905 |
| MDR Report Key | 723174 |
| Report Source | 01,02,03,05 |
| Date Received | 2006-06-05 |
| Date of Report | 2006-05-24 |
| Date Mfgr Received | 2006-05-24 |
| Date Added to Maude | 2006-06-08 |
| 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 | NINA ENGLISH, R.N. |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050822 |
| 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 | UNK |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2006-06-05 |
| Model Number | LEAD |
| Catalog Number | NA |
| Lot Number | UNK |
| 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 | 712251 |
| Manufacturer | MEDTRONIC, INC, NEUROLOGICAL DIV |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | ITREL |
| Baseline Generic Name | LEAD |
| Baseline Model No | LEAD |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-06-05 |