MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2016-03-10 for SPENCER PROBE DEPTH ELECTRODE SD06R-SP05X-000 manufactured by Ad-tech Medical Instrument Corp..
[40131133]
As stated in the describe event section, on (b)(6) 2016, ad-tech's clinical specialist attended another case at (b)(6). She was able to confirm that the patient from this complaint is doing well, with no complications. Customer discarded device after the case.
Patient Sequence No: 1, Text Type: N, H10
[40131136]
Ad-tech received a complaint from a customer in regards to a depth electrode. It was stated that upon placing the first depth electrode, the stylet was difficult to remove and required assistance. Recordings were immediately started from the electrode and the surgeon was satisfied that they were getting a good recording. When closing the patient, it was noticed that cerebral spinal fluid (csf) was leaking from the stylet inlet of the depth electrode. The doctor sutured the inlet closed and it appeared to stop leakage. The neurologist confirmed they were still recording from the depth electrode. Although the customer was able to obtain recordings, this is still a concern. Ad-tech's clinical specialist confirmed that the patient was doing well with no complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2016-00002 |
| MDR Report Key | 5494219 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2016-03-10 |
| Date of Report | 2016-03-10 |
| Date of Event | 2016-02-10 |
| Date Mfgr Received | 2016-02-10 |
| Device Manufacturer Date | 2015-05-31 |
| Date Added to Maude | 2016-03-10 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS KATHLEEN BARLOW |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 1901 WILLIAM STREET |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SPENCER PROBE DEPTH ELECTRODE |
| Generic Name | SPENCER PROBE DEPTH ELECTRODE |
| Product Code | GZL |
| Date Received | 2016-03-10 |
| Catalog Number | SD06R-SP05X-000 |
| Lot Number | 208140588 |
| Device Expiration Date | 2017-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | 1901 WILLIAM STREET RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2016-03-10 |