MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2014-02-18 for SUBDURAL ELECTRODE TS06R-SP10X-000 manufactured by Ad-tech Medical Instrument Corp..
[20656812]
Subdural electrodes placed during phase ii neurosurgery removed percutaneously as bedside procedure. The physician inspected each electrode after its removal. Visually, each electrode appeared to be intact. The pt underwent an angiogram and wada procedure on (b)(6) 2014 during which the physician performing the procedure noted what happened to be electrode fragments left behind under the scalp. The neurosurgeon was notified on (b)(6) 2014 and immediately notified the pt and escalated the info.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5034583 |
| MDR Report Key | 3639455 |
| Date Received | 2014-02-18 |
| Date of Report | 2014-02-13 |
| Date of Event | 2013-12-06 |
| Date Added to Maude | 2014-02-24 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2014-02-18 |
| Model Number | TS06R-SP10X-000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | RACINE WI 53401 US 53401 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-02-18 |