MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-09-29 for LEAD NEURO LEADN NA manufactured by Neurological Division.
[15221431]
Information received via a dbs clinical study report indicates that post dbs implant in 2006, repositioning of the leads occurred the next month and patient experienced altered mentation that may be due to drug regimen changes, slow dbs programming and probable surgical recovery. Prolonged hospitalization was realized for resolution of mental status changes, drug changes and monitoring for dbs stimulation. No report received of device explant and the product has not been returned to the manufacturer. Concomitant medications taken at the time of onset of the adverse event include: sinemet 25/250, sinemet cr50/200, entacapone, pramipexole, lisinopril, lovastatin, quetimipine, omeprazole, tamsulosin. The hcp reports the patient's condition has improved and returned to baseline and the patient was discharged from the hospital. Additional information received via dbs clinical study report shows retro reporting of patient sexual aggression during hospitalization. The next month the patient was re-admitted for device re-cramping, which was attributed to device off time, and resolution of patient sexual aggressiveness was noted. The patient indicated that they experienced an episode of night time wandering, disorientation and confusion. At the time of discharge the patient's condition of residual mild intermittent tremor, dyskinesias and baseline confusion presisted. Patient follow-up indicated improved motoric symptoms and good sleep. The hcp states the serious adverse event appears resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2006-01631 |
| MDR Report Key | 767018 |
| Report Source | 05 |
| Date Received | 2006-09-29 |
| Date of Report | 2006-08-15 |
| Date of Event | 2006-08-03 |
| Date Mfgr Received | 2006-08-15 |
| Date Added to Maude | 2006-10-06 |
| 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 | 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 | 2006-09-29 |
| Model Number | LEADN |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 756238 |
| Manufacturer | NEUROLOGICAL DIVISION |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2006-09-29 |