MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-21 for SPENCER DEPTH ELECTRODE STEREO SD08R-SP10X-000 manufactured by Ad-tech Medical Instrument Corp..
[128396704]
On (b)(6) 2018, pt underwent craniotomy in the operating room for depth electrodes placement to allow invasive eeg monitoring on inpatient unit. On (b)(6) 2018 during planned electrode removal at bedside, the distal end of the 8 contact depth electrode was retained. One of the depth electrodes has a shear in it just past the first contact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5081552 |
| MDR Report Key | 8099846 |
| Date Received | 2018-11-21 |
| Date of Report | 2018-11-13 |
| Date of Event | 2018-11-01 |
| Date Added to Maude | 2018-11-23 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | 0 |
| Brand Name | SPENCER DEPTH ELECTRODE STEREO |
| Generic Name | EEG ELECTRODES / ELECTRODE DEPTH |
| Product Code | GZL |
| Date Received | 2018-11-21 |
| Model Number | SD08R-SP10X-000 |
| Catalog Number | SD08R-SP10X-000 |
| Lot Number | 0123457208140688 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 400 WEST OAKVIEW PKWY OAK CREEK WI 53154 US 53154 |
| Brand Name | SPENCER DEPTH ELECTRODE STEREO |
| Generic Name | EEG ELECTRODES / ELECTRODE DEPTH |
| Product Code | GZL |
| Date Received | 2018-11-21 |
| Model Number | SD08R-SP10X-000 |
| Catalog Number | SD08R-SP10X-000 |
| Lot Number | 0123457208140688 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL |
| Manufacturer Address | 400 WEST OAKVIEW PKWY OAK CREEK WI 53154 US 53154 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-11-21 |