MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-03-15 for LEAD NEURO LEADN NA manufactured by Medtronic, Inc., Neurological Division.
[20025803]
Oem manufacturer reported a patient developed an infection and is receiving treatment after dbs surgical procedure. An hcp reported to the manufacturer, the infection was bilateral and started from the site of entry to the tip of the electrodes. The hcp stated the infection may have been due to the microelectrode, guidetube or the deep brain surgery itself. The physician uses a reusable cannula (guidetube) that is cleaned and sterilized through an internal sterile processing system. The hcp stated the physician and hospital safety departments were investigating internal processing of reusable devices. The hcp reported the patient was improving and continued to be treated for the infection. The patient had the dbs implant in 2007. Additional information has been requested by medtronic from the health care professional regarding the reported event. A supplemental mdr follow-up report will be sent to fda if additional information is received.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2007-00891 |
| MDR Report Key | 829474 |
| Report Source | 00 |
| Date Received | 2007-03-15 |
| Date of Report | 2007-02-12 |
| Date Mfgr Received | 2007-02-12 |
| Date Added to Maude | 2007-03-22 |
| 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 | UNK |
| Product Code | GYZ |
| Date Received | 2007-03-15 |
| 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 | 816863 |
| Manufacturer | MEDTRONIC, INC., NEUROLOGICAL DIVISION |
| Manufacturer Address | 800 53RD AVE., N.E. 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. Required No Informationntervention | 2007-03-15 |