MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-05-08 for SUBDURAL ELECTRODE TS04R-SP10X-0P1 manufactured by Ad-tech Medical Instrument Corp..
[4674226]
Two neurosurgeons removed 8 strip electrodes at bedside and noted that in 2 of the 8 strip electrodes some electrode discs separated from the electrode strips as they were being pulled through the skin. This is an unexpected occurrence. The other 6 electrodes were removed in the usual fashion without any problems and were intact. The separated discs were accounted for and there was no injury to the patient. A skull x-ray was done after the procedure which confirmed that there were no retained.
Patient Sequence No: 1, Text Type: D, B5
[11930802]
These electrodes were removed at bedside. This removal likely was through the burr hole. The electrodes were not removed surgically, as indicated in the electrode directions for use. Percutaneous removal through the burr hole is not in compliance with the device accompanying directions for use. On (b)(4) 2014, ad-tech medical rec'd a copy of the maude event report (b)(4) that (b)(4) submitted to the fda as reportable incident regarding the percutaneous removal of one of ad-tech's strip electrodes, resulting in some contacts (electrode discs) separating from the electrode strips. Dr. (b)(6) informed ad-tech of the event and confirmed that the separated discs were accounted for and none were retained according to the skull x-ray. The catalog number and expiration date for the impacted subdural electrodes (ts04r-sp10x-0p1, lot 208140493) listed on maude event report (b)(4) were incorrect. The catalog number is ts04r-sp10x-0p1 instead of ts04r-sp1-x0p1. The manufacturer date for ts04r-sp10x-0p1, lot 208140493 is 11/2012. As subdural electrodes have a two year shelf life. The expiration date is 11/2014. This mdr reflects the correct catalog number and expiration date of the product. Additionally, (b)(4) indicated that the "device was available for evaluation". (b)(4) confirmed: "the product is not available to be shipped back to the manufacturer. "
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2014-00003 |
| MDR Report Key | 3901890 |
| Report Source | 05 |
| Date Received | 2014-05-08 |
| Date of Report | 2014-05-01 |
| Date of Event | 2014-03-24 |
| Date Mfgr Received | 2014-04-10 |
| Device Manufacturer Date | 2012-11-01 |
| Date Added to Maude | 2014-07-14 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404 |
| Manufacturer Country | US |
| Manufacturer Postal | 53404 |
| Manufacturer Phone | 2626341555 |
| 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 | 2014-05-08 |
| Catalog Number | TS04R-SP10X-0P1 |
| Lot Number | 208140493 |
| Device Expiration Date | 2014-11-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Address | RACINE WI 53404 US 53404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2014-05-08 |