MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-01-18 for DBS 3387 NA manufactured by Medtronic, Inc., Neurological Division.
[582269]
Hcp reported pt fell, hitting neck area and head. Pt went to local emergency room; emergency physician applied "heat treatment" to shoulder and neck area. The pt developed visual disturbances right after emergency room visit. The pt went to the university of minnesota with the system in off state. Reprogramming was done and visual disturbance modified slightly, but returned to original problem within 24 hrs. A ct scan showed no abnormalities. Visual problems still an issue with the system on. A mri found swelling and edema localized around the electrodes. Hcp states swelling should resolve itself. The cause of the edema could be from head impact or "heat treatment". No report of device explantation. A follow up report will be sent if add'l info is received. Refer to medwatch report# 2649622-2007-00221.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2182207-2007-00222 |
| MDR Report Key | 807404 |
| Report Source | 05 |
| Date Received | 2007-01-18 |
| Date of Report | 2006-12-18 |
| Date Mfgr Received | 2006-12-18 |
| Date Added to Maude | 2007-01-24 |
| 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 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 | DBS |
| Generic Name | MHY |
| Product Code | GYZ |
| Date Received | 2007-01-18 |
| Model Number | 3387 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 794915 |
| Manufacturer | MEDTRONIC, INC., NEUROLOGICAL DIVISION |
| 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. Required No Informationntervention | 2007-01-18 |