MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 2006-09-28 for LEAD NEURO LEADN NA manufactured by Medtronic, Inc., Neurological Division.
[17442952]
Mfr rep reports the pt had an infection after one year implant duration at the site of the burr hole and has subsequently not received any benefit from the stimulation. The pt was showing no symptom control. The electrode impedance were checked and found greater than 4,000 ohms and current was less than 15 ua. The mfr was contacted and pt x-rays were recommended due to an apparent open circuit. At the time of this report, there was no indication of device removal and the surgeon involved was going to clean-up the site of infection.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2006-01628 |
| MDR Report Key | 766543 |
| Report Source | 07 |
| Date Received | 2006-09-28 |
| Date of Report | 2006-08-28 |
| Date Mfgr Received | 2006-08-28 |
| Date Added to Maude | 2006-10-04 |
| 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 | 2006-09-28 |
| Model Number | LEADN |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 754429 |
| Manufacturer | MEDTRONIC, INC., NEUROLOGICAL DIVISION |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2006-09-28 |