MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-25 for 3389-40 manufactured by Medtronic Neuromodulation.
[58278346]
Patient Sequence No: 1, Text Type: N, H10
[58278347]
When lead was opened to sterile field, md noticed that one of the electrodes was not adhered correctly. It was loose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 6053726 |
| MDR Report Key | 6053726 |
| Date Received | 2016-10-25 |
| Date of Report | 2016-09-30 |
| Date of Event | 2016-09-30 |
| Report Date | 2016-09-30 |
| Date Reported to FDA | 2016-09-30 |
| Date Reported to Mfgr | 2016-09-30 |
| Date Added to Maude | 2016-10-25 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Generic Name | LEAD, DEEP BRAIN STIMULATOR |
| Product Code | GYZ |
| Date Received | 2016-10-25 |
| Model Number | 3389-40 |
| Catalog Number | 3389-40 |
| Lot Number | VA15X22 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC NEUROMODULATION |
| Manufacturer Address | 7000 CENTRAL AVE., N.E. MINNEAPOLIS MN 55432 US 55432 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-10-25 |