MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,02,03,05 report with the FDA on 2007-11-06 for LDBS 3389 NA manufactured by Medtronic Neuromodulation.
[732458]
Journal reference: derost, et al. "is dbs-stn appropriate to treat severe parkinson disease in an elderly population? " neurology 2007; 68; 17; p 1345-1355. The article describes the results of a retrospective a study comparing the effects, safety and quality of life in parkinsons patients younger than 65 and those 65 and older being treated with bilateral deep brain stimulation of the stn. Patients were followed for up to 2 years after surgery. A number of pt complications were reported. Reportable event(s): one patient attempted suicide. Treatment and outcome info was not provided.
Patient Sequence No: 1, Text Type: D, B5
[7881065]
Due to the limitations of the data, the reportable events are being submitted by complication type. The exact relationship between each pt, the devices used and the complications experienced was not provided. It is possible that each pt may have experienced more than one complication.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2182207-2007-03726 |
| MDR Report Key | 939845 |
| Report Source | 01,02,03,05 |
| Date Received | 2007-11-06 |
| Date of Report | 2007-10-14 |
| Date Mfgr Received | 2007-10-14 |
| Date Added to Maude | 2007-11-15 |
| 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 | 0 |
| Event Location | 3 |
| Manufacturer Contact | CHARLOTTE GASPERLIN |
| Manufacturer Street | 800 53RD AVE., N.E. |
| Manufacturer City | MINNEAPOLIS MN 554325604 |
| Manufacturer Country | US |
| Manufacturer Postal | 554325604 |
| Manufacturer Phone | 7655050823 |
| Manufacturer G1 | MEDTRONIC NEUROMODULATION |
| Manufacturer Street | 800 53RD AVE., N.E. |
| 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 | LDBS |
| Product Code | GYZ |
| Date Received | 2007-11-06 |
| Model Number | 3389 |
| Catalog Number | NA |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 918961 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 800 53RD AVE., N.E. MINNEAPOLIS MN 55421 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2007-11-06 |