MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-10-09 for SUBDURAL STRIP ELECTRODES REFER TO H.10 FOR PRODUCTS manufactured by Ad-tech Medical Instrument Corp..
[90222878]
As stated in the describe event section, each electrode was pulled to deliver it through the exiting stab incision made during the initial surgery. The following electrodes were used in the surgery: catalog number: ts04r-sp10x-000, lot #: 208140624, qty: 4, exp. Date: 2018-10-01, (b)(4); ts04r-sp10x-000, 208140593, 1, 2017/08, n/a (this lot was manufactured prior to the implementation of udi); ts04r-sp10x-000, 208140623, 1, 2018/09, n/a (this lot was manufactured prior to the implementation of udi). 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 hospital acknowledged notification of this addition on 7/14/2014. On 10/9/2017, ad-tech sent the hospital an email reiterating the importance of surgically removing the electrodes and not percutaneously removing them. The directions for use (dfu) was also attached to the email showing the warning.
Patient Sequence No: 1, Text Type: N, H10
[90222879]
On september 6, 2017 ad-tech medical received an email from a customer stating that six (6) 1x4 subdural strips were implanted in a patient on (b)(6) 2017. Upon removal, several of the electrodes broke off. The patient was returned to the or to attempt to remove the electrodes. Ad-tech follow-up with the customer requesting information on how the electrodes were removed. It was stated that "using gentle pressure, each electrode was pulled to deliver it through the exiting stab incision made during the initial surgery. Two (2) of the electrodes on the left, and one on the right, did not deliver through the incisions, resulting in retained hardware. " the patient remains neurologically intact.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2183456-2017-00008 |
| MDR Report Key | 6932054 |
| Date Received | 2017-10-09 |
| Date of Report | 2017-10-06 |
| Date of Event | 2017-08-28 |
| Date Mfgr Received | 2017-09-06 |
| Date Added to Maude | 2017-10-09 |
| 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 | MRS. 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 | 0 |
| Brand Name | SUBDURAL STRIP ELECTRODES |
| Generic Name | SUBDURAL STRIP ELECTRODES |
| Product Code | GYC |
| Date Received | 2017-10-09 |
| Catalog Number | REFER TO H.10 FOR PRODUCTS |
| Lot Number | REFER TO H.10 FOR LOTS |
| 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 | 2017-10-09 |