MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2003-11-17 for LEAD NEURO LEADN NA manufactured by Neuro.
[20891018]
Hcp reported pt hemorrhage during bilateral stn lead placement. A vein was nicked during surgery which caused a bleed in the brokers area of the brain. The pt was commatose, lost feeling on the right side and had congnitive disabilities. After a few months mri showed swelling and "pieces of a clot" so the surgical implant of ipg was postponed. On the way home from transitional care unit the pt had grand mal seizure. Hcp expects full pt recovery. Hcp reported the event was procedure related, no device related. The device was not explanted. A follow-up report will be sent when additional info is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2003-01070 |
| MDR Report Key | 496429 |
| Report Source | 05 |
| Date Received | 2003-11-17 |
| Date of Report | 2003-08-05 |
| Date of Event | 2003-08-05 |
| Date Mfgr Received | 2003-08-05 |
| Date Added to Maude | 2003-11-21 |
| 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 | BARBARA PAHL |
| Manufacturer Street | 710 MEDTRONIC PARKWAY |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | NEURO |
| Manufacturer Street | 800 53RD AVE 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 | PDX |
| Product Code | GYZ |
| Date Received | 2003-11-17 |
| 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 | A |
| Device Sequence No | 1 |
| Device Event Key | 485163 |
| Manufacturer | NEURO |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | LEAD NEURO |
| Baseline Generic Name | PDX |
| Baseline Model No | LEADN |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2003-11-17 |