MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2013-09-17 for DUAL SIDED GRID ELECTRODE DG20A-SP10X-T00 manufactured by Ad-tech Medical Instrument Corp..
[3773806]
It was reported that a dual subdural grid electrode currently implanted in a pt was reversed. The report stated that the doctor did some stimulation tests and identified that the electrode was manufactured backwards. It was also stated that the color coding matched the x-ray marker; however, the contacts that should be on side 2 with the x-ray marker was actually side 1.
Patient Sequence No: 1, Text Type: D, B5
[11128286]
A drawing was sent to the surgeon depicting actual contact placement and the monitoring was successful and logical. Patient is doing well and there were no problems reported at any time. Eval summary: during a complaint investigation team (cit) meeting, it was determined that the product was made correctly to the build template provided but the build template was incorrect. Immediate corrections: on (b)(4) 2013, a drawing that would depict the correct position of the electrode tails and contacts was sent to the customer. Containment: on (b)(4) 2013 all dual sided electrodes in stock were pulled and segregated, until their corresponding code chart, build template and label could be reviewed and verified. Conclusion: a complete sales history was performed to determine which dual sided grid and strip electrodes were manufactured and sold between 2011 and august 20, 2013. Using the data collected; a review of each catalog number's corresponding code chart, build template and label was performed. Through this investigation it was verified that the code chart, build templates and labels were correct. There were a total of (b)(4) dg20a-sp10x-t00 that were manufactured and distributed. (b)(4), the ad-tech distributor in (b)(4). The distributor had (b)(4) remaining device in stock which was returned to ad-tech for investigation. The current inventory on (b)(4) 2013 was pulled and segregated awaiting of their corresponding code chart, build template and label. The batch record review performed on lot 208140464, batch 63725, concluded that there were no issues found during final inspection. The car/capa review revealed that there was no previous car/capa opened for this nonconformance. Through a historical complaint review, it was determined that there was (b)(4) other similar alleged deficiency; however, through investigation it was determined that the alleged deficiency could not be supported and that the customer was reading the electrode incorrectly. Through the returned product analysis, the alleged deficiency was confirmed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2183456-2013-00004 |
| MDR Report Key | 3396662 |
| Report Source | 01,08 |
| Date Received | 2013-09-17 |
| Date of Report | 2013-09-16 |
| Date of Event | 2013-08-20 |
| Date Mfgr Received | 2013-08-20 |
| Device Manufacturer Date | 2012-04-19 |
| Date Added to Maude | 2013-12-24 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 534041876 |
| Manufacturer Country | US |
| Manufacturer Postal | 534041876 |
| Manufacturer Phone | 2626341555 |
| Manufacturer G1 | AD-TECH MEDICAL INSTRUMENT CORP. |
| Manufacturer Street | 1901 WILLIAM ST. |
| Manufacturer City | RACINE WI 53404187 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 53404 1876 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DUAL SIDED GRID ELECTRODE |
| Generic Name | SUBDURAL ELECTRODE |
| Product Code | GYC |
| Date Received | 2013-09-17 |
| Catalog Number | DG20A-SP10X-T00 |
| Lot Number | 208140464 |
| ID Number | BATCH NUMBER: 63725 |
| Device Expiration Date | 2014-04-01 |
| 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 | 1901 WILLIAM ST. RACINE WI 53404187 US 53404 1876 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2013-09-17 |