MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2005-05-18 for ITREL 3387 NA manufactured by Neurological Div, Medtronic, Inc..
[371522]
Consultant reported difficulty with leads during dbs surgery. Several passes were done with micro electric recordings. Pt became non responsive; only able to grunt and flutter eyelids. Implant was discontinued. Pt in hosp for rehabilitation under neurologist care. Consultant stated pt doing fine.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2005-00797 |
| MDR Report Key | 604394 |
| Report Source | 00 |
| Date Received | 2005-05-18 |
| Date of Report | 2005-04-19 |
| Date of Event | 2005-04-13 |
| Date Mfgr Received | 2005-04-19 |
| Date Added to Maude | 2005-05-24 |
| 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 55421 |
| Manufacturer Country | US |
| Manufacturer Postal | 55421 |
| Manufacturer Phone | 7635050856 |
| Manufacturer G1 | NEUROLOGICAL DIV, MEDTRONIC, INC. |
| 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 | ITREL |
| Generic Name | LEAD |
| Product Code | GYZ |
| Date Received | 2005-05-18 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNK |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 594182 |
| Manufacturer | NEUROLOGICAL DIV, MEDTRONIC, INC. |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Baseline Brand Name | DBS |
| Baseline Generic Name | LEAD FOR BRAIN STIMULATION |
| Baseline Model No | 3387 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | STIM DBS LEAD |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 48 |
| Baseline PMA Flag | Y |
| Premarket Approval | P9600 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-05-18 |