MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-10-17 for FORAMEN OVALE ELECTRODES FO04K-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[57628596]
Patient Sequence No: 0, Text Type: N, H10
[57628597]
An elderly female was admitted to rule-out epilepsy pseudodementia. She was prescribed for aeds; taking keppra and dilantin. She had experienced a two year degenerative decline including confusion, memory decline, and staring spells. Admitted for long-term eeg brain wave monitoring. Foreman ovale depth electrodes were surgically placed in the in the operating room under fluoroscopy. When the right lead was removed a few days later, the patient had left sided changes immediately and the ct scan showed an enlarging hemorrhage. The patient was transferred to the intensive care unit and did not improve neurologically. She subsequently died one week later.
Patient Sequence No: 0, Text Type: D, B5
| Report Number | 6033812 |
| MDR Report Key | 6033812 |
| Date Received | 2016-10-17 |
| Date of Report | 2016-10-14 |
| Date of Event | 2016-05-16 |
| Report Date | 2016-10-13 |
| Date Reported to FDA | 2016-10-13 |
| Date Reported to Mfgr | 2016-10-13 |
| Date Added to Maude | 2016-10-17 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| 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 |
| Brand Name | FORAMEN OVALE ELECTRODES |
| Generic Name | ELECTRODE, DEPTH |
| Product Code | GZL |
| Date Received | 2016-10-17 |
| Model Number | FO04K-SP05X-000 |
| Catalog Number | FO04K-SP05X-000 |
| Operator | PHYSICIAN |
| Device Availability | N |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM ST. RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 0 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2016-10-17 |