MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-11 for LEAD NEURO LEADN NA manufactured by Neurological Div, Medtronic, Inc.
[18337161]
Clinical report form indicates the patient is experiencing mentation changes starting in 2006. The patient underwent dbs implant a week earlier and required repositioning of leads 3 days later. Recovery has been complicated by mentation changes starting 2 days after, that may be due to surgical induced edema, history hallucinations, and early dbs programming. Three days later, prolonged hospitalization was required for resolution of mental status changes, drug changes and cautious monitoring for dbs stimulation. The patient's concomitant medications at the time of the event are: sinemet (25/250), sinemet cr (50/200), entacapone, pramipexole, lisinopril, quetiapine, omeprazole, tamsulosin, lovastatin. The adverse event is listed as ongoing. A follow up report will be sent when additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2006-01518 |
| MDR Report Key | 759464 |
| Report Source | 05 |
| Date Received | 2006-09-11 |
| Date of Report | 2006-08-12 |
| Date of Event | 2006-08-08 |
| Date Mfgr Received | 2006-08-12 |
| Date Added to Maude | 2006-09-14 |
| 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 | PDX |
| Product Code | GYZ |
| Date Received | 2006-09-11 |
| 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 | 747384 |
| Manufacturer | NEUROLOGICAL DIV, MEDTRONIC, INC |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-09-11 |