MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2015-09-21 for SUBDURAL ELECTRODE TS04R-SP10X-000 manufactured by Ad-tech Medical Instrument Corp..
[26483996]
As stated in the describe event section, the impacted disc separated (dislodged) from the electrode as the electrode was pulled through the scalp wounds. Prior to this complaint, ad-tech had received several complaints of similar nature. Due to the number of complaints received, a corrective action/preventive action (capa) investigation was initiated to address this issue in may 2014. The probable root cause for this issue (disc dislodgement) was found to be due to percutaneous removal of the electrodes by the end user; ad-tech's directions for use (dfu) specifically states that ad-tech's subdural strip electrodes be removed surgically. As a correction to the capa, the following warning statement was incorporated into ad-tech's dfu in june 2014, "warning: percutaneous removal may result in the separation of materials, requiring surgical intervention to retrieve the electrode and contacts. " a memo was sent to all ad-tech neurosurgeon customers informing them of the addition to the dfu in june 2014. It was confirmed that the doctor associated with this complaint acknowledged notification of this addition on 7/14/2014.
Patient Sequence No: 1, Text Type: N, H10
[26483997]
Ad-tech received a complaint from a customer on (b)(6) 2015 stating that "the electrode disc separated from the electrode as it was pulled on the electrode to remove them. Electrode pulled through the scalp wounds. One (1) disc actually separated totally. " in a follow-up email, the customer reported that the separated disc was accounted for and there was no patient injury. Additionally, there was no delay in surgery as a result of the issue and no medical interventions were required to address this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2015-00006 |
| MDR Report Key | 5092259 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2015-09-21 |
| Date of Report | 2015-09-17 |
| Date of Event | 2015-08-24 |
| Date Mfgr Received | 2015-08-24 |
| Date Added to Maude | 2015-09-21 |
| 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 | SUBDURAL ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2015-09-21 |
| Catalog Number | TS04R-SP10X-000 |
| Lot Number | UNKNOWN |
| 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 | 2015-09-21 |