MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-08-29 for MEDTRONIC 3387 * manufactured by Medtronic Neurological.
[267189]
Deep brain stimulator was placed into lt vim thalamus with proximal lead tunneled under skin and protected with the distal end of the percutaneous extension boot (cut off and placed over lead, screwed down lightly) to protect distal lead from injury during re-operation. Taken back to or twelve days later. Lead (distal) externalized and boot removed. During unscrewing of set screws, the metal screw torqued the entire metal device within the boot 90 degrees, fracturing the lead at the distal end between contact 2 and 3. Boot then cut off the lead, damage inspected. Still able to get lead (with fx into permanent connector housing with appropriate metal/metal contacts. Device implanted. Pt returned three days later for dbs programming with good tremor control, no side effects.
Patient Sequence No: 1, Text Type: D, B5
[284852]
Add'l info received from mfr 11-21-02: mfr has not recieved the device for analysis. They do not recommend capping the lead or staged implants. They do recommend the following for assembly of either the extension or the percutaneous extension to the lead: tighten each set screw slowly until resistance is felt then tighten one half turn further. Caution over tightening the setscrews can result in damage to the lead to the extnesion. For disassembly, they recommend the following: loosen all set screws completely, gently pull on the connection, if resistance is felt check all setscrews and ensure that all are loosened appropriately. The current status of the device is according to the report, remains implanted. No changes to the device related to the event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1026032 |
| MDR Report Key | 414542 |
| Date Received | 2002-08-29 |
| Date of Report | 2002-07-30 |
| Date of Event | 2002-07-23 |
| Date Added to Maude | 2002-09-06 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDTRONIC |
| Generic Name | * |
| Product Code | MUV |
| Date Received | 2002-08-29 |
| Model Number | 3387 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 403581 |
| Manufacturer | MEDTRONIC NEUROLOGICAL |
| Manufacturer Address | 800 53RD AVE NE MINNEAPOLIS MN 554211200 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-08-29 |